Publications by authors named "Craig A Buchman"

136 Publications

Long-term Hearing Preservation and Speech Perception Performance Outcomes With the Slim Modiolar Electrode.

Otol Neurotol 2021 Sep 10. Epub 2021 Sep 10.

Department of Otolaryngology - Head and Neck Surgery, Washington University School of Medicine in St. Louis, St. Louis, MO.

Objective: Describe audiologic outcomes in hearing preservation (HP) cochlear implant candidates using a slim modiolar electrode (SME).

Study Design: Retrospective.

Setting: Tertiary referral center.

Patients: Two hundred three adult cochlear implant patients with preoperative low-frequency pure-tone average (LFPTA) ≤ 80 dB HL that received the SME.

Intervention: Implantation with a SME electrode.

Main Outcome Measures: Primary outcome was postoperative HP, defined as LFPTA ≤80 dB HL. HP status was analyzed at "early" (activation or 3 mo) and "long-term" (6 or 12 mo) time frames using the patient's worst audiogram. Speech perception tests were compared between HP and non-HP cohorts.

Results: Of the 203 HP candidates, the tip fold-over rate was 7.4%. The mean shifts in LFPTA at the "early" and "long-term" time points were 25.9 ± 16.2 dB HL and 29.6 ± 16.9 dB HL, respectively. Of 117 patients with preoperative LFPTA ≤60 dB HL, the early and long-term mean LFPTA shifts were 19.5 ± 12.3 dB HL and 32.6 ± 17.2 dB HL, respectively; early and long-term HP rates were 61.1% and 50.8%, respectively. For patients with preoperative LFPTA ≤80 dB HL, early and long-term HP rates were 45.5% and 43.7%, respectively. No significant difference was observed in postoperative speech perception performance (CNC, AzBio, HINT) at 3, 6, or 12 months between HP versus non-HP groups.

Conclusions: HP is feasible using the SME. While electroacoustic stimulation was not studied in this cohort, HP provided no clear advantage in speech perception abilities in this group of patients. The current reporting standard of what constitutes HP candidacy (preoperative LFPTA ≤80 dB HL) should be reconsidered.
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http://dx.doi.org/10.1097/MAO.0000000000003342DOI Listing
September 2021

Intraoperative Cochlear Nerve Monitoring for Vestibular Schwannoma Resection and Simultaneous Cochlear Implantation in Neurofibromatosis Type 2: A Case Series.

Oper Neurosurg (Hagerstown) 2021 Jul 31. Epub 2021 Jul 31.

Department of Otolaryngology - Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.

Background: Neurofibromatosis type 2 (NF2) often results in profound hearing loss and cochlear implantation is an emerging hearing rehabilitation option. However, cochlear implant (CI) outcomes in this population vary, and intraoperative monitoring to predict cochlear nerve viability and subsequent outcomes is not well-established.

Objective: To review the use of intraoperative electrically evoked cochlear nerve monitoring in patients with NF2 simultaneous translabyrinthine (TL) vestibular schwannoma (VS) resection and cochlear implantation.

Methods: A retrospective review was performed of 3 patients with NF2 that underwent simultaneous TL VS resection and cochlear implantation with electrical auditory brainstem response (eABR) measured throughout tumor resection. Patient demographics, preoperative assessments, surgical procedures, and outcomes were reviewed.

Results: Patients 1 and 3 had a reliable eABR throughout tumor removal. Patient 2 had eABR pretumor removal, but post-tumor removal eABR presence could not be reliably determined because of electrical artifact interference. All patients achieved auditory percepts upon CI activation. Patients 1 and 2 experienced a decline in CI performance after 1 yr and after 3 mo, respectively. Patient 3 continues to perform well at 9 mo. Patients 2 and 3 are daily users of their CI.

Conclusion: Cochlear implantation is attainable in cases of NF2-associated VS resection. Intraoperative eABR may facilitate cochlear nerve preservation during tumor removal, though more data and long-term outcomes are needed to refine eABR methodology and predictive value for this population.
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http://dx.doi.org/10.1093/ons/opab274DOI Listing
July 2021

Pediatric Bilateral Sensorineural Hearing Loss: Minimum Test Battery and Referral Criteria for Cochlear Implant Candidacy Evaluation.

Otolaryngol Head Neck Surg 2021 Jul 20:1945998211027352. Epub 2021 Jul 20.

Washington University School of Medicine, St Louis, Missouri, USA.

Among the various cochlear implant systems approved by the Food and Drug Administration, current labeling for pediatric usage encompasses (1) bilateral profound bilateral sensorineural hearing loss in children aged 9 to 24 months and bilateral severe to profound sensorineural hearing loss in children older than 2 years; (2) use of appropriately fitted hearing aids for 3 months (this can be waived if there is evidence of ossification); and (3) demonstration of limited progress with auditory, speech, and language development. Pediatric guidelines require children to have significantly worse speech understanding before qualifying for cochlear implantation. The early years of life have been shown to be critical for speech and language development, and auditory deprivation is especially detrimental during this crucial time.Level of evidence: 2.
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http://dx.doi.org/10.1177/01945998211027352DOI Listing
July 2021

Hearing Preservation After Cochlear Reimplantation Using Electrocochleography: A Case Report.

Laryngoscope 2021 Oct 3;131(10):2348-2351. Epub 2021 Jul 3.

Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St. Louis, St. Louis, Missouri, U.S.A.

Studies have shown that hearing preservation is possible in the context of reimplantation, but residual hearing could not be predicted or expected in these cases. We describe a case in which a patient with mild to profound sensorineural hearing loss who underwent cochlear implantation with a lateral wall array and had hearing preserved postoperatively. She developed facial nerve stimulation which was unresponsive to reprogramming. Using electrocochleography to measure intracochlear trauma during the insertion process, the patient underwent reimplantation with a perimodiolar electrode and hearing was preserved postoperatively. This case demonstrates the potential to use electrocochleography for hearing preservation during reimplantation. Laryngoscope, 131:2348-2351, 2021.
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http://dx.doi.org/10.1002/lary.29734DOI Listing
October 2021

Intracochlear Electrocochleography and Speech Perception Scores in Cochlear Implant Recipients.

Laryngoscope 2021 Oct 21;131(10):E2681-E2688. Epub 2021 May 21.

Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, U.S.A.

Objectives/hypothesis: Previous studies have demonstrated that electrocochleography (ECochG) measurements made at the round window prior to cochlear implant (CI) electrode insertion can account for 47% of the variability in 6-month speech perception scores. Recent advances have made it possible to use the apical CI electrode to record intracochlear responses to acoustic stimuli. Study objectives were to determine 1) the relationship between intracochlear ECochG response amplitudes and 6-month speech perception scores and 2) to determine the relationship between behavioral auditory thresholds and ECochG threshold estimates. The hypothesis was that intracochlear ECochG response amplitudes made immediately after electrode insertion would be larger than historical controls (at the extracochlear site) and explain more variability in speech perception scores.

Study Design: Prospective case series.

Methods: Twenty-two adult CI recipients with varying degrees of low-frequency hearing had intracochlear ECochG measurements made immediately after CI electrode insertion using 110 dB SPL tone bursts. Tone bursts were centered at five octave-spaced frequencies between 125 and 2,000 Hz.

Results: There was no association between intracochlear ECochG response amplitudes and speech perception scores. But, the data suggest a mild to moderate relationship between preoperative behavioral audiometric testing and intraoperative ECochG threshold estimates.

Conclusion: Performing intracochlear ECochG is highly feasible and results in larger response amplitudes, but performing ECochG before, rather than after, CI insertion may provide a more accurate assessment of a patient's speech perception potential.

Level Of Evidence: 4 Laryngoscope, 131:E2681-E2688, 2021.
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http://dx.doi.org/10.1002/lary.29629DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8440360PMC
October 2021

Relationship Between Electrocochleography, Angular Insertion Depth, and Cochlear Implant Speech Perception Outcomes.

Ear Hear 2021 Jul-Aug 01;42(4):941-948

Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, North Carolina, USA.

Objectives: Electrocochleography (ECochG), obtained before the insertion of a cochlear implant (CI) array, provides a measure of residual cochlear function that accounts for a substantial portion of variability in postoperative speech perception outcomes in adults. It is postulated that subsequent surgical factors represent independent sources of variance in outcomes. Prior work has demonstrated a positive correlation between angular insertion depth (AID) of straight arrays and speech perception under the CI-alone condition, with an inverse relationship observed for precurved arrays. The purpose of the present study was to determine the combined effects of ECochG, AID, and array design on speech perception outcomes.

Design: Participants were 50 postlingually deafened adult CI recipients who received one of three straight arrays (MED-EL Flex24, MED-EL Flex28, and MED-EL Standard) and two precurved arrays (Cochlear Contour Advance and Advanced Bionics HiFocus Mid-Scala). Residual cochlear function was determined by the intraoperative ECochG total response (TR) measured before array insertion, which is the sum of magnitudes of spectral components in response to tones of different stimulus frequencies across the speech spectrum. The AID was then determined with postoperative imaging. Multiple linear regression was used to predict consonant-nucleus-consonant (CNC) word recognition in the CI-alone condition at 6 months postactivation based on AID, TR, and array design.

Results: Forty-one participants received a straight array and nine received a precurved array. The AID of the most apical electrode contact ranged from 341° to 696°. The TR measured by ECochG accounted for 43% of variance in speech perception outcomes (p < 0.001). A regression model predicting CNC word scores with the TR tended to underestimate the performance for precurved arrays and deeply inserted straight arrays, and to overestimate the performance for straight arrays with shallower insertions. When combined in a multivariate linear regression, the TR, AID, and array design accounted for 72% of variability in speech perception outcomes (p < 0.001).

Conclusions: A model of speech perception outcomes that incorporates TR, AID, and array design represents an improvement over a model based on TR alone. The success of this model shows that peripheral factors including cochlear health and electrode placement may play a predominant role in speech perception with CIs.
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http://dx.doi.org/10.1097/AUD.0000000000000985DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8217403PMC
August 2021

Prevalence, Surgical Management, and Audiologic Impact of Sigmoid Sinus Dehiscence Causing Pulsatile Tinnitus.

Otol Neurotol 2021 01;42(1):82-91

Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri.

Objective: To evaluate the prevalence, surgical management, and audiologic impact of pulsatile tinnitus caused by sigmoid sinus dehiscence.

Study Design And Setting: Retrospective chart review at a tertiary care hospital.

Patients: Adults with unilateral pulsatile tinnitus attributable to sigmoid sinus dehiscence who underwent resurfacing between January 2010 and January 2020.

Interventions: Transmastoid sigmoid resurfacing.

Main Outcome Measures: Resolution of pulsatile tinnitus; audiologic outcomes; complications; tinnitus etiologies.

Results: Nineteen patients (89.4% women) had surgery for suspected sigmoid sinus dehiscence. The mean dehiscence size was 6.1 mm (range, 1-10.7 mm). Eight patients had concurrent sigmoid sinus diverticulum and one patient also had jugular bulb dehiscence. Only two patients (10.5%) had the defect identified by radiology. Low-frequency pure-tone average, measured at frequencies of 250 and 500 Hz, showed a significant median improvement of 8.8 dB following resurfacing (18.8 dB versus 10.0 dB, p = 0.02). The majority of patients had complete resolution of pulsatile tinnitus (16/19, 84.2%). Of those without complete resolution, two patients had partial response and one patient had no improvement. There were no significant complications. Of 41 consecutively tracked patients with a pulsatile tinnitus chief complaint, sigmoid pathology represented 32% of cases.

Conclusions: Sigmoid sinus dehiscence represents a common vascular cause of pulsatile tinnitus that, if properly assessed, may be amenable to surgical intervention. Sigmoid sinus resurfacing is safe, does not require decompression, and may improve low-frequency hearing. Radiographic findings of dehiscence are often overlooked without a high index of clinical suspicion. Its relationship with transverse sinus pathology and idiopathic intracranial hypertension remain unclear.
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http://dx.doi.org/10.1097/MAO.0000000000002846DOI Listing
January 2021

Is cochlear synapse loss an origin of low-frequency hearing loss associated with endolymphatic hydrops?

Hear Res 2020 12 21;398:108099. Epub 2020 Oct 21.

Department of Otolaryngology - Head and Neck Surgery, Washington University School of Medicine in St. Louis, 660 South Euclid Avenue, Saint Louis, MO 63110, USA; Program in Audiology and Communication Sciences, Washington University School of Medicine in St. Louis, St. Louis, MO, USA. Electronic address:

There is a strong association between endolymphatic hydrops and low-frequency hearing loss, but the origin of the hearing loss remains unknown. A reduction in the number of cochlear afferent synapses between inner hair cells and auditory nerve fibres may be the origin of the low-frequency hearing loss, but this hypothesis has not been directly tested in humans or animals. In humans, measurements of hearing loss and postmortem temporal-bone based measurements of endolymphatic hydrops are generally separated by large amounts of time. In animals, there has not been a good objective, physiologic, and minimally invasive measurement of low-frequency hearing. We overcame this obstacle with the combined use of a reliable surgical approach to ablate the endolymphatic sac in guinea pigs and create endolymphatic hydrops, the Auditory Nerve Overlapped Waveform to measure low-frequency hearing loss (≤ 1 kHz), and immunohistofluorescence-based confocal microscopy to count cochlear synapses. Results showed low- and mid-(1-4 kHz) frequency hearing loss at all postoperative days, 1, 4, and 30. There was no statistically significant loss of cochlear synapses, and there was no correlation between synapse loss and hearing function. We conclude that cochlear afferent synaptic loss is not the origin of the low-frequency hearing loss in the early days following endolymphatic sac ablation. Understanding what is, and is not, the origin of a hearing loss can help guide preventative and therapeutic development.
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http://dx.doi.org/10.1016/j.heares.2020.108099DOI Listing
December 2020

Cochlear Implant Outcomes Following Vestibular Schwannoma Resection: Systematic Review.

Otol Neurotol 2020 10;41(9):1190-1197

Department of Otolaryngology-Head and Neck Surgery.

Objective: Hearing loss remains a significant morbidity for patients with vestibular schwannomas (VS). A growing number of reports suggest audibility with cochlear implantation following VS resection; however, there is little consensus on preferred timing and cochlear implant (CI) performance.

Data Sources: A systematic literature search of the Ovid Medline, Embase, Scopus, and clinicaltrails.gov databases was performed on 9/7/2018. PRISMA reporting guidelines were followed.

Study Selection: Included studies reported CI outcomes in an ear that underwent a VS resection. Untreated VSs, radiated VSs, and CIs in the contralateral ear were excluded.

Data Extraction: Primary outcomes were daily CI use and attainment of open-set speech. Baseline tumor and patient characteristics were recorded. Subjects were divided into two groups: simultaneous CI placement with VS resection (Group 1) versus delayed CI placement after VS resection (Group 2).

Data Synthesis: Twenty-nine articles with 93 patients met inclusion criteria. Most studies were poor quality due to their small, retrospective design. Group 1 had 46 patients, of whom 80.4% used their CI on a daily basis and 50.0% achieved open-set speech. Group 2 had 47 patients, of whom 87.2% used their CI on a daily basis and 59.6% achieved open-set speech. Group 2 had more NF2 patients and larger tumors. CI timing did not significantly impact outcomes.

Conclusions: Audibility with CI after VS resection is feasible. Timing of CI placement (simultaneous versus delayed) did not significantly affect performance. Overall, 83.9% used their CI on a daily basis and 54.8% achieved open-set speech.
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http://dx.doi.org/10.1097/MAO.0000000000002784DOI Listing
October 2020

Unilateral Cochlear Implants for Severe, Profound, or Moderate Sloping to Profound Bilateral Sensorineural Hearing Loss: A Systematic Review and Consensus Statements.

JAMA Otolaryngol Head Neck Surg 2020 10;146(10):942-953

Department of Otorhinolaryngology and Auditory and Voice Surgery, University of Tokyo Hospital, Tokyo, Japan.

Importance: Cochlear implants are a treatment option for individuals with severe, profound, or moderate sloping to profound bilateral sensorineural hearing loss (SNHL) who receive little or no benefit from hearing aids; however, cochlear implantation in adults is still not routine.

Objective: To develop consensus statements regarding the use of unilateral cochlear implants in adults with severe, profound, or moderate sloping to profound bilateral SNHL.

Design, Setting, And Participants: This study was a modified Delphi consensus process that was informed by a systematic review of the literature and clinical expertise. Searches were conducted in the following databases: (1) MEDLINE In-Process & Other Non-Indexed Citations and Ovid MEDLINE, (2) Embase, and (3) the Cochrane Library. Consensus statements on cochlear implantation were developed using the evidence identified. This consensus process was relevant for the use of unilateral cochlear implantation in adults with severe, profound, or moderate sloping to profound bilateral SNHL. The literature searches were conducted on July 18, 2018, and the 3-step Delphi consensus method took place over the subsequent 9-month period up to March 30, 2019.

Main Outcomes And Measures: A Delphi consensus panel of 30 international specialists voted on consensus statements about cochlear implantation, informed by an SR of the literature and clinical expertise. This vote resulted in 20 evidence-based consensus statements that are in line with clinical experience. A modified 3-step Delphi consensus method was used to vote on and refine the consensus statements. This method consisted of 2 rounds of email questionnaires and a face-to-face meeting of panel members at the final round. All consensus statements were reviewed, discussed, and finalized at the face-to-face meeting.

Results: In total, 6492 articles were identified in the searches of the electronic databases. After removal of duplicate articles, 74 articles fulfilled all of the inclusion criteria and were used to create the 20 evidence-based consensus statements. These 20 consensus statements on the use of unilateral cochlear implantation in adults with SNHL were relevant to the following 7 key areas of interest: level of awareness of cochlear implantation (1 consensus statement); best practice clinical pathway from diagnosis to surgery (3 consensus statements); best practice guidelines for surgery (2 consensus statements); clinical effectiveness of cochlear implantation (4 consensus statements); factors associated with postimplantation outcomes (4 consensus statements); association between hearing loss and depression, cognition, and dementia (5 consensus statements); and cost implications of cochlear implantation (1 consensus statement).

Conclusions And Relevance: These consensus statements represent the first step toward the development of international guidelines on best practices for cochlear implantation in adults with SNHL. Further research to develop consensus statements for unilateral cochlear implantation in children, bilateral cochlear implantation, combined electric-acoustic stimulation, unilateral cochlear implantation for single-sided deafness, and asymmetrical hearing loss in children and adults may be beneficial for optimizing hearing and quality of life for these patients.
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http://dx.doi.org/10.1001/jamaoto.2020.0998DOI Listing
October 2020

Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older: A Secondary Analysis of a Nonrandomized Clinical Trial.

JAMA Otolaryngol Head Neck Surg 2020 10;146(10):925-932

Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.

Importance: Hearing loss, especially moderate to severe forms, has the potential to negatively affect an individual's physical, social, emotional, and cognitive well-being. Moreover, having ineffective binaural hearing increases difficulty understanding speech in noise and leads to a greater degree of social isolation and loneliness and a reduced quality of life (QoL).

Objective: To explore the audiometric and holistic effects of cochlear implantation in a group of adults 65 years or older compared with an optimized bilateral hearing aid condition.

Design, Setting, And Participants: This ad hoc secondary analysis of a prospective, single-subject, repeated-measures nonrandomized clinical trial included 13 cochlear implantation centers across the United States. Participants 65 years or older with postlingual bilateral moderate-to-profound sensorineural hearing loss with aided Consonant-Vowel Nucleus-Consonant (CNC) word scores in quiet of 40% or less in the ear to undergo implantation and 50% or less in the contralateral ear were included in the analysis. Baseline QoL testing was performed after 1 month of optimized bilateral hearing aid use. Participants were enrolled from February 20, 2017, to May 3, 2018, and follow-up was completed December 21, 2018. Data were analyzed from March 25, 2019, to March 31, 2020.

Interventions: Unilateral implantation with a slim, modiolar cochlear implant device. Hearing aid use in the contralateral ear was required through the 6-month primary end-point interval.

Main Outcomes And Measures: The primary objective was to evaluate speech perception before and 6 months after activation of a new cochlear implant. Secondary objectives were QoL metrics in the everyday listening condition before and 6 months after implantation.

Results: Seventy participants (51 men [73%]) with a median age of 74 (range, 65-91) years were included in the analysis. No major adverse events occurred. Mixed-model analysis with estimated marginal means and 95% CIs compared preimplantation baseline performance with 6-month postimplantation performance. A clinically important improvement in CNC words was shown in the bimodal condition, with a mean difference of 37.2% (95% CI, 32.0%-42.4%), and in the unilateral (cochlear implant only) condition, with a mean difference of 44.1% (95% CI, 39.0%-49.2%). A clinically important improvement in noise (AzBio sentences signal-to-noise ratio of +10 dB) was also shown, with a mean difference of 21.6% (95% CI, 15.7%-27.5%) in the bimodal condition and 24.5% (95% CI, 18.3%-30.7%) in the unilateral condition. The Health Utilities Index Mark 3 multiple-attribute score improved by 0.186 (95% CI, 0.136-0.234); the Speech, Spatial, and Qualities of Hearing Scale total score improved by 2.58 (95% CI, 2.18-2.99); and a novel Device Use Questionnaire reported 94% of participants were satisfied with overall hearing in the everyday listening condition.

Conclusions And Relevance: This subgroup analysis of patients 65 years or older enrolled in a within-subject clinical trial of cochlear implantation demonstrated clinically meaningful audiometric and QoL benefit with an acceptable risk profile. These findings suggest that cochlear implantation in older adults may facilitate the concept of healthy aging.

Trial Registration: ClinicalTrials.gov Identifier: NCT03007472.
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http://dx.doi.org/10.1001/jamaoto.2020.1585DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7453343PMC
October 2020

Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users: A Nonrandomized Controlled Trial.

JAMA Otolaryngol Head Neck Surg 2020 10;146(10):916-924

Department of Otolaryngology-Head & Neck Surgery, Washington University in St Louis, St Louis, Missouri.

Importance: Cochlear implants were approved for use in adults in the 1980s, but use remains low owing to a lack of awareness regarding cochlear implantation candidacy criteria and expected outcomes. There have been limited, small series examining the safety and effectiveness of cochlear implantation in adult hearing aid (HA) users with and without mild cognitive impairment (MCI).

Objective: To investigate the safety and effectiveness of a single-ear cochlear implant in a group of optimized adult HA users with and without MCI across a variety of domains.

Design, Setting, And Participants: In this nonrandomized controlled trial, a multicenter, prospective, repeated-measures investigation was conducted at 13 US institutions. The setting was academic and community-based cochlear implant programs. Eligible participants were 100 adults (aged >18 years) with postlinguistic onset of bilateral moderate sloping to profound or worse sensorineural hearing loss (≤20 years' duration). Fluent English speakers underwent an optimized bilateral HA trial for at least 30 days. Individuals with aided Consonant-Vowel Nucleus-Consonant (CNC) word score in quiet of 40% or less correct in the ear to be implanted and 50% or less correct in the contralateral ear were offered cochlear implants. The first participant was enrolled on February 20, 2017, and the last participant was enrolled on May 3, 2018. The final follow-up was on December 21, 2018.

Interventions: Participants received the same cochlear implant system and contralateral HA.

Main Outcomes And Measures: The primary outcome measure was speech understanding in quiet (CNC word score) using both the cochlear implant and opposite ear HA. Secondary outcome measures included the following: adverse events; speech understanding in noise (AzBio signal-to-noise ratio of +10 db [+10 SNR]) Health Utilities Index Mark 3 (HUI3); Speech, Spatial, and Qualities of Hearing Questionnaire 49 (SSQ49); and Montreal Cognitive Assessment (MoCA).

Results: The median age at cochlear implantation of the 96 patients included in the trial was 71 years (range, 23-91 years), and 62 patients (65%) were male. Three serious adverse events requiring revision surgery occurred, and all resolved without sequelae. By 6 months after activation, the absolute marginal mean change in CNC word score and AzBio +10 SNR was 40.5% (95% CI, 35.9%-45.0%) and 24.1% (95% CI, 18.9%-29.4%), respectively. Ninety-one percent (87 of 96) of participants had a clinically important improvement (>15%) in the CNC word score in the implant ear. Mild cognitive impairment (MoCA total score ≤25) was observed in 48 of 81 study participants (59%) at baseline. Speech perception marginal mean improvements were similar between individuals with and without baseline MCI, with values of 40.9% (95% CI, 35.2%-46.6%) and 39.6% (95% CI, 31.8%-47.4%), respectively, for CNC word score and 27.5% (95% CI, 21.0%-33.9%) and 17.8% (95% CI, 9.0%-26.6%), respectively, for AzBio +10 SNR. Statistically significant and clinically important improvements in the HUI3 and SSQ49 were evident at 6 months.

Conclusions And Relevance: The findings of this nonrandomized controlled trial seem to indicate that cochlear implants are safe and effective in restoring speech understanding in both quiet and noise and improve quality of life in individuals with and without MCI.

Trial Registration: ClinicalTrials.gov Identifier: NCT03007472.
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http://dx.doi.org/10.1001/jamaoto.2020.1584DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7453346PMC
October 2020

Assessment of Cochlear Implants for Adult Medicare Beneficiaries Aged 65 Years or Older Who Meet Expanded Indications of Open-Set Sentence Recognition: A Multicenter Nonrandomized Clinical Trial.

JAMA Otolaryngol Head Neck Surg 2020 10;146(10):933-941

Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.

Importance: Current indications for Medicare beneficiaries to receive a cochlear implant are outdated. Multichannel cochlear implant systems may be effective when provided to Medicare beneficiaries using expanded indications.

Objective: To examine the effectiveness of cochlear implants, as measured by improvement on the AzBio Sentence Test, for newly implanted Medicare beneficiaries who meet the expanded indications of an AzBio Sentence Test score of 41% to 60% in their best-aided condition.

Design, Setting, And Participants: A multicenter nonrandomized trial examined preoperative and postoperative speech recognition, telephone communication, hearing device benefit, health utility, and quality of life for 34 participants enrolled at 8 different centers who received a cochlear implant between September 17, 2014, and July 10, 2018. All participants were 65 years or older, had bilateral moderate to profound hearing loss, and had a best-aided preoperative AzBio Sentence Test score in quiet of 41% to 60%. Analysis was performed on an intention-to-treat basis. Statistical analysis of final results took place from July 29 to October 1, 2019.

Intervention: Multichannel cochlear implants.

Main Outcomes And Measures: The study examined the a priori hypothesis that the cochlear implant would improve the AzBio Sentence Test score in the best-aided condition by 25% or more and in the implanted ear-alone condition by 30% or more. The study additionally examined word and telephone recognition and examined device benefit, health utility, and quality of life.

Results: A total of 34 participants received a cochlear implant; 31 (23 men [74%]; median age, 73.6 years [range, 65.7-85.1 years]) completed testing through the 6-month evaluation, and 29 completed testing through the 12-month evaluation. Median preoperative AzBio Sentence Test scores were 53% (range, 26%-60%) for the best-aided condition and 24% (range, 0%-53%) for the cochlear implant-alone condition; median scores 12 months after implantation improved to 89% (range, 36%-100%) for the best-aided condition and 77% (range, 13%-100%) for the cochlear implant-alone condition. This outcome represents a median change of 36% (range, -22% to 75%) for the best-aided condition (lower bound of 1-sided 95% CI, 31%) and a median change of 53% (range, -15% to 93%) for the cochlear implant-alone condition (lower bound of 1-sided 95% CI, 45%).

Conclusions And Relevance: Intervention with a cochlear implant was associated with improved sentence, word, and telephone recognition in adult Medicare beneficiaries whose preoperative AzBio Sentence Test scores were between 41% and 60%. These findings support expansion of the Center for Medicare & Medicaid current indications for cochlear implants.

Trial Registration: ClinicalTrials.gov Identifier: NCT02075229.
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http://dx.doi.org/10.1001/jamaoto.2020.2286DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7453340PMC
October 2020

Long-Term Influence of Electrode Array Length on Speech Recognition in Cochlear Implant Users.

Laryngoscope 2021 04 1;131(4):892-897. Epub 2020 Aug 1.

Department of Otolaryngology-Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, U.S.A.

Objectives/hypothesis: Results from a prospective trial demonstrated better speech recognition for cochlear implant (CI) recipients implanted with a long lateral wall electrode array compared to subjects with a short array after 1 year of listening experience. As short array recipients may require an extended adaptation period, this study investigated whether differences in speech recognition continued through 4 years of CI use.

Study Design: Long-term follow-up of a prospective randomized trial.

Methods: Subjects were randomized to receive a MED-EL medium (24 mm) or standard (31.5 mm) array. Linear mixed models compared speech recognition between cohorts with word recognition in quiet and sentence recognition in noise at 1, 3, 6, 12, 24, and 48 months postactivation. Postoperative imaging and electric frequency filters were reviewed to assess the influence of frequency-to-place mismatch and angular separation between neighboring contacts, a metric associated with peripheral spectral selectivity.

Results: Long (31.5 mm) array recipients demonstrated superior speech recognition out to 4 years postactivation. There was a significant effect of angular separation between contacts, with more closely spaced contacts associated with poorer speech recognition. There was no significant effect of mismatch, yet this may have been obscured by changes in frequency filters over time.

Conclusions: Conventional MED-EL CI recipients implanted with 31.5-mm arrays experience better speech recognition than 24-mm array recipients, initially and with long-term listening experience. The benefit conferred by longer arrays in the present cohort can be partially attributed to more widely spaced electrode contacts, presumably a result of reduced channel interaction.

Level Of Evidence: 2 Laryngoscope, 131:892-897, 2021.
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http://dx.doi.org/10.1002/lary.28949DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855603PMC
April 2021

A Revised Surgical Approach to Induce Endolymphatic Hydrops in the Guinea Pig.

J Vis Exp 2020 06 4(160). Epub 2020 Jun 4.

Department of Otolaryngology, Head and Neck Surgery, Washington University School of Medicine in St. Louis;

Endolymphatic hydrops is an enlargement of scala media that is most often associated with Meniere's disease, though the pathophysiologic mechanism(s) remain unclear. In order to adequately study the attributes of endolymphatic hydrops, such as the origins of low-frequency hearing loss, a reliable model is needed. The guinea pig is a good model because it hears in the low-frequency regions that are putatively affected by endolymphatic hydrops. Previous research has demonstrated that endolymphatic hydrops can be induced surgically via intradural or extradural approaches that involve drilling on the endolymphatic duct and sac. However, whether it was possible to create an endolymphatic hydrops model using an extradural approach that avoided dangerous drilling on the endolymphatic duct and sac was unknown. The objective of this study was to demonstrate a revised extradural approach to induce experimental endolymphatic hydrops at 30 days post-operatively by obliterating the endolymphatic sac and injuring the endolymphatic duct with a fine pick. The sample size consisted of seven guinea pigs. Functional measurements of hearing were made and temporal bones were subsequently harvested for histologic analysis. The approach had a success rate of 86% in achieving endolymphatic hydrops. The risk of cerebrospinal fluid leak was minimal. No perioperative deaths or injuries to the posterior semicircular canal occurred in the sample. The presented method demonstrates a safe and reliable way to induce endolymphatic hydrops at a relatively quick time point of 30 days. The clinical implications are that the presented method provides a reliable model to further explore the origins of low-frequency hearing loss that can be associated endolymphatic hydrops.
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http://dx.doi.org/10.3791/60597DOI Listing
June 2020

For Whom Do Cochlear Implants Work Best?

JAMA Otolaryngol Head Neck Surg 2020 07;146(7):603-604

Department of Otolaryngology-Head & Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.

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http://dx.doi.org/10.1001/jamaoto.2020.0678DOI Listing
July 2020

Negative-Pressure Aerosol Cover for COVID-19 Tracheostomy.

JAMA Otolaryngol Head Neck Surg 2020 07;146(7):672-674

Department of Otolaryngology-Head & Neck Surgery, Washington University in St Louis School of Medicine, St Louis, Missouri.

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http://dx.doi.org/10.1001/jamaoto.2020.1081DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7189331PMC
July 2020

Immediate and 1-Year Outcomes with a Slim Modiolar Cochlear Implant Electrode Array.

Otolaryngol Head Neck Surg 2020 May 17;162(5):731-736. Epub 2020 Mar 17.

Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri, USA.

Objective: To explore the immediate and 1-year outcomes of patients who underwent implantation with the slim modiolar electrode (SME).

Study Design: Consecutive case series with chart review.

Setting: Tertiary referral academic center.

Subject And Methods: Between May 2016 and August 2018, a total of 326 cochlear implantations (CIs) were performed. Intraoperative x-rays were performed in all cases to identify tip rollovers. Scalar location was identified for 76 CIs that had postoperative computed tomography reconstructions. Speech outcomes were measured at 3, 6, and 12 months with consonant-nucleus-consonant word and AzBio sentences in quiet and noise (+10-dB signal-to-noise ratio). Preservation of hearing was defined as maintaining a low-frequency pure tone average ≤80 dB at 250 and 500 Hz.

Results: Among 326 CIs, 23 (7%) had tip rollovers. Postoperative reconstructions revealed 5 of 76 (6.6%) scalar translocations. A subset of 177 cases met criteria for evaluation of speech perception scores. The marginal mean differences between presurgery and 12 months for speech tests were as follows: consonant-nucleus-consonant, 43.7 (95% CI, 39.8-47.6); AzBio in quiet, 49.7 (95% CI, 44.9-54.4); and AzBio in noise, 29.9 (95% CI, 25.2-34.7). Sixty-one patients were identified with preservable hearing (low-frequency pure tone average ≤80 dB), and 12 of 61 (20%) preserved hearing at 1 year.

Conclusion: CI with SME provides reliable scala tympani insertion in a consistent perimodiolar position. An initially increased tip rollover rate improved with case volume and sheath design improvement. For long-term outcomes, speech performance was comparable to that of other cochlear implants. While hearing preservation for the SME may be better than prior perimodiolar electrodes, consistent outcomes are unlikely.
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http://dx.doi.org/10.1177/0194599820907336DOI Listing
May 2020

Incidence of Infectious Complications Following Cochlear Implantation in Children and Adults.

JAMA 2020 01;323(2):182-183

Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine in St Louis, St Louis, Missouri.

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http://dx.doi.org/10.1001/jama.2019.18611DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990693PMC
January 2020

Intracochlear Electrocochleography: Influence of Scalar Position of the Cochlear Implant Electrode on Postinsertion Results.

Otol Neurotol 2019 06;40(5):e503-e510

Department of Otolaryngology - Head and Neck Surgery, The Ohio State University, Columbus, Ohio.

Hypothesis: Electrocochleography (ECochG) recorded during cochlear implant (CI) insertion from the apical electrode in conjunction with postinsertion ECochG can identify electrophysiologic differences that exist between groups with and without a translocation of the array from the scala tympani (ST) into the scala vestibuli (SV).

Background: Translocation of the CI electrode from ST into SV can limit performance postoperatively. ECochG markers of trauma may be able to aid in the ability to detect electrode array-induced trauma/scalar translocation intraoperatively.

Methods: Twenty-one adult CI patients were included. Subjects were postoperatively parsed into two groups based on analysis of postoperative imaging: 1) ST (n = 14) insertion; 2) SV (n = 7) insertion, indicating translocation of the electrode. The ECochG response elicited from a 500 Hz acoustic stimulus was recorded from the lead electrode during insertion when the distal electrode marker was at the round window, and was compared to the response recorded from a basal electrode (e13) after complete insertion.

Results: No statistically significant change in mean ECochG magnitude was found in either group between recording intervals. There was a mean loss of preoperative pure-tone average of 52% for the nontranslocation group and 94% for the translocation group.

Conclusions: Intraoperative intracochlear ECochG through the CI array provides a unique opportunity to explore the impact of the CI electrode on the inner ear. Specifically, a translocation of the array from ST to SV does not seem to change the biomechanics of the cochlear region that lies basal to the area of translocation in the acute period.
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http://dx.doi.org/10.1097/MAO.0000000000002202DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6530483PMC
June 2019

Intracochlear Electrocochleography: Response Patterns During Cochlear Implantation and Hearing Preservation.

Ear Hear 2019 Jul/Aug;40(4):833-848

Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, NC.

Objectives: Electrocochleography (ECochG) obtained through a cochlear implant (CI) is increasingly being tested as an intraoperative monitor during implantation with the goal of reducing surgical trauma. Reducing trauma should aid in preserving residual hearing and improve speech perception overall. The purpose of this study was to characterize intracochlear ECochG responses throughout insertion in a range of array types and, when applicable, relate these measures to hearing preservation. The ECochG signal in cochlear implant subjects is complex, consisting of hair cell and neural generators with differing distributions depending on the etiology and history of hearing loss. Consequently, a focus was to observe and characterize response changes as an electrode advances.

Design: In 36 human subjects, responses to 90 dB nHL tone bursts were recorded both at the round window (RW) and then through the apical contact of the CI as the array advanced into the cochlea. The specific setup used a sterile clip in the surgical field, attached to the ground of the implant with a software-controlled short to the apical contact. The end of the clip was then connected to standard audiometric recording equipment. The stimuli were 500 Hz tone bursts at 90 dB nHL. Audiometry for cases with intended hearing preservation (12/36 subjects) was correlated with intraoperative recordings.

Results: Successful intracochlear recordings were obtained in 28 subjects. For the eight unsuccessful cases, the clip introduced excessive line noise, which saturated the amplifier. Among the successful subjects, the initial intracochlear response was a median 5.8 dB larger than the response at the RW. Throughout insertion, modiolar arrays showed median response drops after stylet removal while in lateral wall arrays the maximal median response magnitude was typically at the deepest insertion depth. Four main patterns of response magnitude were seen: increases > 5 dB (12/28), steady responses within 5 dB (4/28), drops > 5 dB (from the initial response) at shallow insertion depths (< 15 mm deep, 7/28), or drops > 5 dB occurring at deeper depths (5/28). Hearing preservation, defined as < 80 dB threshold at 250 Hz, was successful in 9/12 subjects. In these subjects, an intracochlear loss of response magnitude afforded a prediction model with poor sensitivity and specificity, which improved when phase, latency, and proportion of neural components was considered. The change in hearing thresholds across cases was significantly correlated with various measures of the absolute magnitudes of response, including RW response, starting response, maximal response, and final responses (p's < 0.05, minimum of 0.0001 for the maximal response, r's > 0.57, maximum of 0.80 for the maximal response).

Conclusions: Monitoring the cochlea with intracochlear ECochG during cochlear implantation is feasible, and patterns of response vary by device type. Changes in magnitude alone did not account for hearing preservation rates, but considerations of phase, latency, and neural contribution can help to interpret the changes seen and improve sensitivity and specificity. The correlation between the absolute magnitude obtained either before or during insertion of the ECochG and the hearing threshold changes suggest that cochlear health, which varies by subject, plays an important role.
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http://dx.doi.org/10.1097/AUD.0000000000000659DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6534483PMC
January 2020

Development of a Mixed Reality Platform for Lateral Skull Base Anatomy.

Otol Neurotol 2018 12;39(10):e1137-e1142

Department of Biomedical Engineering, Washington University School of Engineering and Applied Science, St. Louis, Missouri.

Objectives: A mixed reality (MR) headset that enables three-dimensional (3D) visualization of interactive holograms anchored to specific points in physical space was developed for use with lateral skull base anatomy. The objectives of this study are to: 1) develop an augmented reality platform using the headset for visualization of temporal bone structures, and 2) measure the accuracy of the platform as an image guidance system.

Methods: A combination of semiautomatic and manual segmentation was used to generate 3D reconstructions of soft tissue and bony anatomy of cadaver heads and temporal bones from 2D computed tomography images. A Mixed-Reality platform was developed using C# programming to generate interactive 3D holograms that could be displayed in the HoloLens headset. Accuracy of visual surface registration was determined by target registration error between seven predefined points on a 3D holographic skull and 3D printed model.

Results: Interactive 3D holograms of soft tissue, bony anatomy, and internal ear structures of cadaveric models were generated and visualized in the MR headset. Software user interface was developed to allow for user control of the virtual images through gaze, voice, and gesture commands. Visual surface point matching registration was used to align and anchor holograms to physical objects. The average target registration error of our system was 5.76 mm ± 0.54.

Conclusion: In this article, we demonstrate that an MR headset can be applied to display interactive 3D anatomic structures of the temporal bone that can be overlaid on physical models. This technology has the potential to be used as an image guidance tool during anatomic dissection and lateral skull base surgery.
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http://dx.doi.org/10.1097/MAO.0000000000001995DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6242747PMC
December 2018

Residual Cochlear Function in Adults and Children Receiving Cochlear Implants: Correlations With Speech Perception Outcomes.

Ear Hear 2019 May/Jun;40(3):577-591

Department of Otolaryngology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

Objectives: Variability in speech perception outcomes with cochlear implants remains largely unexplained. Recently, electrocochleography, or measurements of cochlear potentials in response to sound, has been used to assess residual cochlear function at the time of implantation. Our objective was to characterize the potentials recorded preimplantation in subjects of all ages, and evaluate the relationship between the responses, including a subjective estimate of neural activity, and speech perception outcomes.

Design: Electrocochleography was recorded in a prospective cohort of 284 candidates for cochlear implant at University of North Carolina (10 months to 88 years of ages). Measurement of residual cochlear function called the "total response" (TR), which is the sum of magnitudes of spectral components in response to tones of different stimulus frequencies, was obtained for each subject. The TR was then related to results on age-appropriate monosyllabic word score tests presented in quiet. In addition to the TR, the electrocochleography results were also assessed for neural activity in the forms of the compound action potential and auditory nerve neurophonic.

Results: The TR magnitude ranged from a barely detectable response of about 0.02 µV to more than 100 µV. In adults (18 to 79 years old), the TR accounted for 46% of variability in speech perception outcome by linear regression (r = 0.46; p < 0.001). In children between 6 and 17 years old, the variability accounted for was 36% (p < 0.001). In younger children, the TR accounted for less of the variability, 15% (p = 0.012). Subjects over 80 years old tended to perform worse for a given TR than younger adults at the 6-month testing interval. The subjectively assessed neural activity did not increase the information compared with the TR alone, which is primarily composed of the cochlear microphonic produced by hair cells.

Conclusions: The status of the auditory periphery, particularly of hair cells rather than neural activity, accounts for a large fraction of variability in speech perception outcomes in adults and older children. In younger children, the relationship is weaker, and the elderly differ from other adults. This simple measurement can be applied with high throughput so that peripheral status can be assessed to help manage patient expectations, create individually-tailored treatment plans, and identify subjects performing below expectations based on residual cochlear function.
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http://dx.doi.org/10.1097/AUD.0000000000000630DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6533622PMC
December 2019

Effects of Cochlear Implantation on Binaural Hearing in Adults With Unilateral Hearing Loss.

Trends Hear 2018 Jan-Dec;22:2331216518771173

1 Department of Otolaryngology/Head and Neck Surgery, 2331 University of North Carolina School of Medicine , Chapel Hill, NC, USA.

A FDA clinical trial was carried out to evaluate the potential benefit of cochlear implant (CI) use for adults with unilateral moderate-to-profound sensorineural hearing loss. Subjects were 20 adults with moderate-to-profound unilateral sensorineural hearing loss and normal or near-normal hearing on the other side. A MED-EL standard electrode was implanted in the impaired ear. Outcome measures included: (a) sound localization on the horizontal plane (11 positions, -90° to 90°), (b) word recognition in quiet with the CI alone, and (c) masked sentence recognition with the target at 0° and the masker at -90°, 0°, or 90°. This battery was completed preoperatively and at 1, 3, 6, 9, and 12 months after CI activation. Normative data were also collected for 20 age-matched control subjects with normal or near-normal hearing bilaterally. The CI improved localization accuracy and reduced side bias. Word recognition with the CI alone was similar to performance of traditional CI recipients. The CI improved masked sentence recognition when the masker was presented from the front or from the side of normal or near-normal hearing. The binaural benefits observed with the CI increased between the 1- and 3-month intervals but appeared stable thereafter. In contrast to previous reports on localization and speech perception in patients with unilateral sensorineural hearing loss, CI benefits were consistently observed across individual subjects, and performance was at asymptote by the 3-month test interval. Cochlear implant settings, consistent CI use, and short duration of deafness could play a role in this result.
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http://dx.doi.org/10.1177/2331216518771173DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5950506PMC
March 2019

Minimum Reporting Standards for Adult Cochlear Implantation.

Otolaryngol Head Neck Surg 2018 08 20;159(2):215-219. Epub 2018 Mar 20.

4 Department of Otolaryngology-Head and Neck Surgery, School of Medicine, Washington University, St Louis, Missouri, USA.

This article outlines new minimum standards for reporting adult cochlear implant outcomes. These standards have been endorsed by the Implantable Hearing Devices Committee and the Hearing Committee of the American Academy of Otolaryngology-Head and Neck Surgery. The lack of a standardized method for reporting outcomes following cochlear implantation in clinical trials has hampered the ability of investigators to draw comparisons across studies. Variability in data reported in articles and presentation formats inhibits meta-analyses, making it impossible to accumulate the large patient cohorts needed for statistically significant inference. While investigators remain unrestricted in publishing their adult cochlear implant outcome data in additional formats that they believe to be valuable, they should include the presently proposed minimal data set to facilitate interstudy comparability and consistency of reporting.
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http://dx.doi.org/10.1177/0194599818764329DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6135063PMC
August 2018

Response Changes During Insertion of a Cochlear Implant Using Extracochlear Electrocochleography.

Ear Hear 2018 Nov/Dec;39(6):1146-1156

Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, North Carolina, USA.

Objectives: Electrocochleography is increasingly being utilized as an intraoperative monitor of cochlear function during cochlear implantation (CI). Intracochlear recordings from the advancing electrode can be obtained through the device by on-board capabilities. However, such recordings may not be ideal as a monitor because the recording electrode moves in relation to the neural and hair cell generators producing the responses. The purposes of this study were to compare two extracochlear recording locations in terms of signal strength and feasibility as intraoperative monitoring sites and to characterize changes in cochlear physiology during CI insertion.

Design: In 83 human subjects, responses to 90 dB nHL tone bursts were recorded both at the round window (RW) and then at an extracochlear position-either adjacent to the stapes or on the promontory just superior to the RW. Recording from the fixed, extracochlear position continued during insertion of the CI in 63 cases.

Results: Before CI insertion, responses to low-frequency tones at the RW were roughly 6 dB larger than when recording at either extracochlear site, but the two extracochlear sites did not differ from one another. During CI insertion, response losses from the promontory or adjacent to the stapes stayed within 5 dB in ≈61% (38/63) of cases, presumably indicating atraumatic insertions. Among responses which dropped more than 5 dB at any time during CI insertion, 12 subjects showed no response recovery, while in 13, the drop was followed by partial or complete response recovery by the end of CI insertion. In cases with recovery, the drop in response occurred relatively early (<15 mm insertion) compared to those where there was no recovery. Changes in response phase during the insertion occurred in some cases; these may indicate a change in the distributions of generators contributing to the response.

Conclusions: Monitoring the electrocochleography during CI insertion from an extracochlear site reveals insertions that are potentially atraumatic, show interaction with cochlear structures followed by response recovery, or show interactions such that response losses persist to the end of recording.
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http://dx.doi.org/10.1097/AUD.0000000000000571DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139286PMC
April 2019

Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes.

Otol Neurotol 2018 03;39(3):299-305

Department of Otolaryngology/Head and Neck Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina.

Objective: To demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic Stimulation (EAS) System, for adults with residual low-frequency hearing and severe-to-profound hearing loss in the mid to high frequencies.

Study Design: Prospective, repeated measures.

Setting: Multicenter, hospital.

Patients: Seventy-three subjects implanted with PULSAR or SONATA cochlear implants with FLEX electrode arrays.

Intervention: Subjects were fit postoperatively with an audio processor, combining electric stimulation and acoustic amplification.

Main Outcome Measures: Unaided thresholds were measured preoperatively and at 3, 6, and 12 months postactivation. Speech perception was assessed at these intervals using City University of New York sentences in noise and consonant-nucleus-consonant words in quiet. Subjective benefit was assessed at these intervals via the Abbreviated Profile of Hearing Aid Benefit and Hearing Device Satisfaction Scale questionnaires.

Results: Sixty-seven of 73 subjects (92%) completed outcome measures for all study intervals. Of those 67 subjects, 79% experienced less than a 30 dB HL low-frequency pure-tone average (250-1000 Hz) shift, and 97% were able to use the acoustic unit at 12 months postactivation. In the EAS condition, 94% of subjects performed similarly to or better than their preoperative performance on City University of New York sentences in noise at 12 months postactivation, with 85% demonstrating improvement. Ninety-seven percent of subjects performed similarly or better on consonant-nucleus-consonant words in quiet, with 84% demonstrating improvement.

Conclusion: The MED-EL EAS System is a safe and effective treatment option for adults with normal hearing to moderate sensorineural hearing loss in the low frequencies and severe-to-profound sensorineural hearing loss in the high frequencies who do not benefit from traditional amplification.
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http://dx.doi.org/10.1097/MAO.0000000000001691DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5821485PMC
March 2018

Effect of Cochlear Implantation on Quality of Life in Adults with Unilateral Hearing Loss.

Audiol Neurootol 2017 4;22(4-5):259-271. Epub 2018 Jan 4.

Department of Otolaryngology/Head and Neck Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.

Objective: Patients with moderate-to-profound sensorineural hearing loss in 1 ear and normal hearing in the contralateral ear, known as unilateral hearing loss (UHL) or single-sided deafness (SSD), may experience improved quality of life with the use of a cochlear implant (CI) in the affected ear. Quality of life assessment before and after implantation may reveal changes to aspects of hearing beyond those explicitly evaluated with behavioral measures.

Methods: The present report completed 2 experiments investigating quality of life outcomes in CI recipients with UHL. The first experiment assessed quality of life during the 1st year of device use with 3 questionnaires: the Speech, Spatial, and Qualities of Hearing Scale (SSQ), the Abbreviated Profile of Hearing Aid Benefit (APHAB), and the Tinnitus Handicap Inventory. Twenty subjects were evaluated preoperatively and 1, 3, 6, 9, and 12 months post-activation. Quality of life results were compared over the study period using traditional scoring methods and the SSQ pragmatic subscales. Subscales specific to localization and speech perception in noise were compared to behavioral measures at the preoperative and 12-month intervals. The 2nd experiment evaluated quality of life preoperatively and at the 12-month interval for CI recipients with UHL and CI recipients with bilateral hearing loss, including conventional CI users and those listening with electric-acoustic stimulation (EAS). The 3 cohorts differed in CI candidacy criteria, including the amount of residual hearing in the contralateral ear.

Results: For subjects with moderate-to-profound UHL, receipt of a CI significantly improved quality of life, with benefits noted as early as 1 month after initial activation. The UHL cohort reported less perceived difficulty at the pre- and postoperative intervals than the conventional CI and EAS cohorts, which may be due to the presence of the normal-hearing ear. Each group experienced a significant benefit in quality of life on the APHAB with CI use.

Conclusions: Cochlear implantation in cases of substantial UHL may offer significant improvements in quality of life. Quality of life measures revealed a reduction in perceived tinnitus severity and subjective improvements in speech perception in noise, spatial hearing, and listening effort. While self-report of difficulties were lower for the UHL cohort than the conventional CI and EAS cohorts, subjects in all 3 groups reported an improvement in quality of life with CI use.
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http://dx.doi.org/10.1159/000484079DOI Listing
May 2019

Early Outcomes With a Slim, Modiolar Cochlear Implant Electrode Array.

Otol Neurotol 2018 01;39(1):e28-e33

Department of Otolaryngology, Washington University in St. Louis, St. Louis.

Objective: To describe outcomes from cochlear implantation with a new, slim modiolar electrode array.

Study Design: Retrospective cohort study.

Setting: Tertiary referral centers.

Patients: Adult cochlear implant candidates.

Interventions: Cochlear implantation with CI532 (Cochlear Corp).

Main Outcome Measures: Pre- and postoperative speech perception scores, operative details, and postoperative computed tomography (CT) reconstructions of array location.

Results: One hundred seventeen patients are implanted to date. There were eight tip rollovers identified with intraoperative x-ray and resolved with reinsertion. An additional rollover was identified on postoperative CT. CT reconstructions in 17 of 23 patients showed complete scala tympani placement with a wrap factor of 58% (range 53-64%) and a mean insertion angle of 406 degrees (range 360-452 degrees). Three implants demonstrated array translocation with electrodes in the scala vestibuli. Consonant-nucleus-consonant word scores improved from 10% preoperatively to 48% at 3 months postoperatively. Pure-tone thresholds were preserved postoperatively in 37 to 52% of patients across frequencies from 250 to 4000 Hz. Functional pure-tone thresholds (≤80 dB) were recorded in 9 to 25% of patients.

Conclusion: CI532 array insertion results in consistent scala tympani location and provides expected audiologic performance. Initial hearing preservation results are not consistent with current electro-acoustic arrays.
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http://dx.doi.org/10.1097/MAO.0000000000001652DOI Listing
January 2018

Pediatric Auditory Brainstem Implantation: Surgical, Electrophysiologic, and Behavioral Outcomes.

Ear Hear 2018 Mar/Apr;39(2):326-336

Department of Otolaryngology-Head and Neck Surgery, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

Objectives: The objectives of this study were to demonstrate the safety of auditory brainstem implant (ABI) surgery and document the subsequent development of auditory and spoken language skills in children without neurofibromatosis type II (NFII).

Design: A prospective, single-subject observational study of ABI in children without NFII was undertaken at the University of North Carolina at Chapel Hill. Five children were enrolled under an investigational device exemption sponsored by the investigators. Over 3 years, patient demographics, medical/surgical findings, complications, device mapping, electrophysiologic measures, audiologic outcomes, and speech and language measures were collected.

Results: Five children without NFII have received ABIs to date without permanent medical sequelae, although 2 children required treatment after surgery for temporary complications. All children wear their device daily, and the benefits of sound awareness have developed slowly. Intra-and postoperative electrophysiologic measures augmented surgical placement and device programming. The slow development of audition skills precipitated limited changes in speech production but had little impact on growth in spoken language.

Conclusions: ABI surgery is safe in young children without NFII. Benefits from device use develop slowly and include sound awareness and the use of pattern and timing aspects of sound. These skills may augment progress in speech production but progress in language development is dependent upon visual communication. Further monitoring of this cohort is needed to better delineate the benefits of this intervention in this patient population.
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http://dx.doi.org/10.1097/AUD.0000000000000501DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5821574PMC
March 2019
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