HiRes ultra series cochlear implant field recall: failure rates and early outcomes
Winchester, Arianna; Kay-Rivest, Emily; Friedmann, David R; McMenomey, Sean O; Shapiro, William H; Roland, J Thomas; Waltzman, Susan; Jethanamest, Daniel
OBJECTIVE/UNASSIGNED:Evaluate rates of Advanced Bionics Ultra 3D/Ultra cochlear implant failure in the setting of a worldwide device recall and report surgical and auditory outcomes after revision. METHODS/UNASSIGNED:Retrospective chart review was performed for adult and pediatric patients implanted with at risk devices at our center from 2016 to 2020. Device failure rates, surgical, and auditory outcomes were recorded and analyzed. RESULTS/UNASSIGNED: = 0.95). DISCUSSION/UNASSIGNED:Patients with device failure due to this field action performed well after revision implantation. Patients with bilateral at-risk devices but evidence of unilateral failure may elect to undergo simultaneous empiric revision of the contralateral device. Three patients who elected to change device manufacturers on revision have variable results that require further investigation. CONCLUSIONS/UNASSIGNED:Patients requiring revision for a device field action overall perform well. At-risk devices continue to require monitoring as a growing number are likely to fail over time.
American Cochlear Implant Alliance Task Force Guidelines for Clinical Assessment and Management of Adult Cochlear Implantation for Single-Sided Deafness
Dillon, Margaret T; Kocharyan, Armine; Daher, Ghazal S; Carlson, Matthew L; Shapiro, William H; Snapp, Hillary A; Firszt, Jill B
The indications for cochlear implantation have expanded to include individuals with profound sensorineural hearing loss in the impaired ear and normal hearing (NH) in the contralateral ear, known as single-sided deafness (SSD). There are additional considerations for the clinical assessment and management of adult cochlear implant candidates and recipients with SSD as compared to conventional cochlear implant candidates with bilateral moderate to profound sensorineural hearing loss. The present report reviews the current evidence relevant to the assessment and management of adults with SSD. A systematic review was also conducted on published studies that investigated outcomes of cochlear implant use on measures of speech recognition in quiet and noise, sound source localization, tinnitus perception, and quality of life for this patient population. Expert consensus and systematic review of the current literature were combined to provide guidance for the clinical assessment and management of adults with SSD.
Predictive Value of Transimpedance Matrix Measurements to Detect Electrode Tip Foldover
Kay-Rivest, Emily; McMenomey, Sean O; Jethanamest, Daniel; Shapiro, William H; Friedmann, David R; Waltzman, Susan B; Roland, J Thomas
OBJECTIVE:To evaluate the ability of the transimpedance matrix (TIM) measurement to detect cochlear implant electrode tip foldover by comparing results to a "gold standard," the intraoperative plain film radiograph. STUDY DESIGN/METHODS:Retrospective case series. SETTING/METHODS:Tertiary referral hospital. PATIENTS/METHODS:One hundred three patients who underwent cochlear implantation between June 2020 and August 2021. INTERVENTIONS/METHODS:Intraoperative electrophysiologic monitoring (electrode impedances, neural response telemetry, and TIM measurement) and modified Stenver's view plain film radiographs. MAIN OUTCOME MEASURES/METHODS:Identification of tip foldover on both TIM and plain films. RESULTS:In total, 103 patients (117 ears) had both a TIM measurement and intraoperative X-ray available for review, including 68 adults and 35 children. One hundred patients (85%) received the Cochlear Slim Modiolar electrode. Tip foldovers were noted in three of 117 implants (2.5%). In all cases, TIM was able to detect the foldover, and the electrode arrays were reinserted with the patients still under anesthesia, with repeat X-ray demonstrating a normal configuration. Two other abnormal TIM patterns were identified. One was in a patient with an obstructed cochlea in whom only 10 electrodes could be inserted, the other was in a patient with a common cavity abnormality. One additional patient underwent electrode repositioning intraoperatively because of overinsertion. In this patient, the TIM appeared to be within normal limits, but the over-insertion was apparent on X-ray. Overall, the sensitivity and specificity of TIM measurements in detecting electrode tip foldover were both 100%. CONCLUSION/CONCLUSIONS:TIM measurements were able to accurately identify tip foldovers. More research is needed to define the adjunctive role of TIM as an intraoperative measure.
Cochlear Implant Outcomes in CHARGE Syndrome: Updated Perspectives
Kay-Rivest, Emily; McMenomey, Sean O; Jethanamest, Daniel; Roland, J Thomas; Shapiro, William H; Waltzman, Susan B; Friedmann, David R
OBJECTIVE:To evaluate outcomes of auditory implants in children with CHARGE syndrome and describe the evolution in management of hearing loss in this complex population. METHODS:A retrospective case review was performed at a tertiary referral center. Children with CHARGE syndrome who received either a cochlear implant (CI) or auditory brainstem implant (ABI) were included. Clinical records, demographic information, CHARGE features, neuroimaging, audiology, hearing rehabilitation interventions, operative notes, and outcomes were reviewed. RESULTS:Thirteen children with CHARGE syndrome underwent a total of 19 cochlear implants between 2008 and 2020. Among the congenitally deafened children (nâ€Š=â€Š9), six underwent bilateral implantation (five simultaneous and one sequential). Bilateral implantation was performed even in the presence of diminutive-appearing cochlear nerves. The average age of implantation was 1.1â€Šyears, and the mean device use time was 9.4â€Šhours per day. Patients showed improvements in subjective family assessment related to hearing. In this group, two patients use oral communication, five use total communication, and two use sign language exclusively. Among the children with progressive hearing loss, the mean age of hearing deterioration was 4.4â€Šyears of age, and the device use time on average was 9.8â€Šhours per day. The highest performer in the cohort was a child who lost hearing in their only hearing ear at age 4 and had normal cochleovestibular anatomy on that side. One child received an auditory brainstem implant at age two after deriving no benefit from a CI and can detect environmental sounds but is currently a nonuser. Over time, we noted that implantation occurred earlier in life and that practice has shifted toward bilateral implantation. CONCLUSIONS:Compared to a previous institutional cohort, children evaluated in this study were often implanted at a younger age and bilaterally with significantly improved outcomes. A CI evaluation should be considered in children with CHARGE syndrome to maximize sensory input and auditory ability.
Stimulating the Cochlear Apex Without Longer Electrodes: Preliminary Results With a New Approach
Landsberger, David M; Stupak, Natalia; Spitzer, Emily R; Entwisle, Lavin; Mahoney, Laurel; Waltzman, Susan B; McMenomey, Sean; Friedmann, David R; Svirsky, Mario A; Shapiro, William; Roland, J Thomas
OBJECTIVE:To investigate a new surgical and signal processing technique that provides apical stimulation of the cochlea using a cochlear implant without extending the length of the electrode array. PATIENTS/METHODS:Three adult patients who underwent cochlear implantation using this new technique. INTERVENTIONS/METHODS:The patients received a cochlear implant. The surgery differed from the standard approach in that a ground electrode was placed in the cochlear helicotrema via an apical cochleostomy rather than in its typical location underneath the temporalis muscle. Clinical fitting was modified such that low frequencies were represented using the apically placed electrode as a ground. MAIN OUTCOME MEASURES/METHODS:Pitch scaling and speech recognition. RESULTS:All surgeries were successful with no complications. Pitch scaling demonstrated that use of the apically placed electrode as a ground lowered the perceived pitch of electric stimulation relative to monopolar stimulation. Speech understanding was improved compared with preoperative scores. CONCLUSIONS:The new surgical approach and clinical fitting are feasible. A lower pitch is perceived when using the apically placed electrode as a ground relative to stimulation using an extracochlear ground (i.e., monopolar mode), suggesting that stimulation can be provided more apically without the use of a longer electrode array. Further work is required to determine potential improvements in outcomes and optimal signal processing for the new approach.
Cochlear Implant Outcomes in Neurofibromatosis Type 2: Implications for Management
Deep, Nicholas L; Patel, Evan J; Shapiro, William H; Waltzman, Susan B; Jethanamest, Daniel; McMenomey, Sean O; Roland, John Thomas; Friedmann, David R
OBJECTIVE:To describe our institutional experience with cochlear implantation (CI) for rehabilitation of hearing loss in Neurofibromatosis type 2 (NF2) patients. STUDY DESIGN/METHODS:Retrospective review between 1989 and 2019. SETTING/METHODS:Tertiary-care center. PATIENTS/METHODS:Twenty-four patients (67% female, mean age 45.6years) with NF2. Management of their ipsilateral vestibular schwannoma included microsurgery (n=12), stereotactic radiation (n=5), and observation (n=7). INTERVENTIONS/METHODS:Cochlear implantation. MAIN OUTCOME MEASURES/METHODS:Ability to obtain open-set speech, daily device usage and long-term device benefit. RESULTS:All patients achieved some degree of sound awareness with CI. Nineteen patients (79%) achieved open-set speech understanding with a mean word-recognition score of 43% (range 0-88%). Patients with tumors 1.5 cm or less demonstrated the better speech understanding, without significant differences among treatment modalities. For tumors greater than 1.5 cm, patients who underwent microsurgery had a lower rate of open-set speech understanding compared to those treated with radiation or observation. Regular daily device use in 83% of patients was found. Long-term use (>10years) was observed in several patients, though some ultimately required reimplantation with an auditory brainstem implant due to progressive tumor growth. Mean follow-up duration was 4.1 years (range 0.4-15). CONCLUSIONS:Cochlear implantation can be an effective treatment for hearing loss in NF2 patients provided the cochlear nerve is intact, regardless of prior management for the ipsilateral tumor. The degree of benefit varies and is influenced by tumor size. Management strategies that preserve the cochlear nerve maximize the interval during which a CI could be of benefit to NF2 patients.
Cochlear Implantation in Adults With Single-sided Deafness: Outcomes and Device Use
Deep, Nicholas L; Spitzer, Emily R; Shapiro, William H; Waltzman, Susan B; Roland, J Thomas; Friedmann, David R
OBJECTIVE:To describe our experience with adults undergoing cochlear implantation (CI) for treatment of single-sided deafness (SSD). STUDY DESIGN/METHODS:Retrospective case review. SETTING/METHODS:Tertiary referral center. PATIENTS/METHODS:Fifty-three adults with SSD. INTERVENTIONS/METHODS:Unilateral CI. MAIN OUTCOME MEASURES/METHODS:Speech perception testing in quiet and noise, tinnitus suppression, and device usage from datalogs. RESULTS:The mean age at CI was 53.2 years (SD 11.9). The mean duration of deafness was 4.0 years (SD 7.8). The most common etiology was idiopathic sudden SNHL (50%). Word recognition improved from 8.7% (SD 15) preoperatively to 61.8% (SD 20) at a mean follow-up of 3.3 years (SD 1.8) (pâ€Š<â€Š0.0001). Adaptive speech recognition testing in the "binaural with CI" condition (speech directed toward the front and noise toward the normal hearing ear) revealed a significant improvement by 2.6-dB SNR compared to the preoperative unaided condition (pâ€Š=â€Š0.0002) and by 3.6-dB SNR compared to when a device to route sound to the contralateral side was used (pâ€Š<â€Š0.0001). Tinnitus suppression was reported to be complete in 23 patients (43%) and improved in 20 patients (38%) while the device was on. The addition of the CI did not lead to a decrement in hearing performance in any spatial configuration. Device usage averaged 8.7 (SD 3.7) hours/day. CONCLUSIONS:Cochlear implantation in adult SSD patients can suppress tinnitus and achieve speech perception outcomes comparable with CI in conventional candidates. Modest improvements in spatial hearing were also observed and primarily attributable to the head shadow effect. Careful patient selection and counseling regarding potential benefits are important to optimize outcomes.
Assessing temporal responsiveness of primary stimulated neurons in auditory brainstem and cochlear implant users
Azadpour, Mahan; Shapiro, William H; Roland, J Thomas; Svirsky, Mario A
The reasons why clinical outcomes with auditory brainstem implants (ABIs) are generally poorer than with cochlear implants (CIs) are still somewhat elusive. Prior work has focused on differences in processing of spectral information due to possibly poorer tonotopic representation and higher channel interaction with ABIs than with CIs. In contrast, this study examines the hypothesis that a potential contributing reason for poor speech perception in ABI users may be the relative lack of temporal responsiveness of the primary neurons that are stimulated by the ABI. The cochlear nucleus, the site of ABI stimulation, consists of different neuron types, most of which have much more complex responses than the auditory nerve neurons stimulated by a CI. Temporal responsiveness of primary stimulated neurons was assessed in a group of ABI and CI users by measuring recovery of electrically evoked compound action potentials (ECAPs) from single-pulse forward masking. Slower ECAP recovery tended to be associated with poorer hearing outcomes in both groups. ABI subjects with the longest recovery time had no speech understanding or even no hearing sensation with their ABI device; speech perception for the one CI outlier with long ECAP recovery time was well below average. To the extent that ECAP recovery measures reveal temporal properties of the primary neurons that receive direct stimulation form neural prosthesis devices, they may provide a physiological underpinning for clinical outcomes of auditory implants. ECAP recovery measures may be used to determine which portions of the cochlear nucleus to stimulate, and possibly allow us to enhance the stimulation paradigms.
Cochlear Implantation in Children with Single-Sided Deafness
Deep, Nicholas L; Gordon, Steven A; Shapiro, William H; Waltzman, Susan B; Roland, J Thomas; Friedmann, David R
OBJECTIVE:To describe our experience with children undergoing unilateral cochlear implantation (CI) for treatment of single-sided deafness (SSD). STUDY DESIGN/METHODS:Retrospective case series. METHODS:A retrospective case review from a tertiary referral center involving 14 pediatric patients (<18â€‰years) with SSD who underwent unilateral CI. Speech perception testing in quiet and noise in the CI-only and bimodal conditions with at least 1â€‰year of device use and device usage from data logs represent the main outcome measures. RESULTS:The mean age at CI was 5.0â€‰years (median 4.4, range 1.0-11.8â€‰years). The mean duration of deafness was 3.0â€‰years (median 2.4, range 0.6-7.0â€‰years). Mean follow-up was 3.4â€‰years. Speech perception testing with a minimum of 1â€‰year post-CI was available in eight patients. The mean word recognition scores (WRS) in the CI-only condition was 56%; a significant improvement from baseline. Testing in background noise with spatially separated speech and noise revealed that patients scored as well or better with the CI-on versus CI-off in all conditions and in no cases was interference from the CI noted. Data logs were reviewed for device usage which revealed an average use of 6.5â€‰hr/d. CONCLUSION/CONCLUSIONS:Cochlear implantation is a viable treatment option for pediatric SSD in this self-selected cohort. Open-set speech and improvement in background noise can be achieved. Careful patient selection and thorough counseling on expectations is paramount to achieving successful outcomes. LEVEL OF EVIDENCE/METHODS:IV Laryngoscope, 2020.
From Bimodal Hearing to Sequential Bilateral Cochlear Implantation in Children-A Within-Subject Comparison
Deep, Nicholas L; Green, Janet E; Chen, Sophia; Shapiro, William H; McMenomey, Sean O; Thomas Roland, J; Waltzman, Susan B
OBJECTIVE:To evaluate the performance changes after sequential bilateral cochlear implantation in a pediatric population of bimodal cochlear implant (CI) users. To evaluate the factors which influence the parental and recipient decision to discontinue hearing aid use and seek a second implant. STUDY DESIGN/METHODS:Retrospective case review, within-subject comparison. SETTING/METHODS:Tertiary referral center. PATIENTS/METHODS:Thirty-one pediatric (<18 yr) bimodal CI users who underwent sequential bilateral CI. INTERVENTIONS/METHODS:Sequential bilateral CI. MAIN OUTCOME MEASURES/METHODS:Parental and/or recipient's reasons for discontinuing their hearing aid and pursuing a second implant, device usage from datalogs, speech understanding in the bimodal and bilateral CI condition. RESULTS:Parents/patients were motivated to pursue sequential bilateral CI based on their positive performance with CI1, the expectation of further improvement with a second CI, and the prospect of having a second independently functional ear. In the bimodal condition, mean word recognition score (WRS), sentence recognition in quiet (SIQ), and sentence recognition in noise (SIN) scores were 87.4, 97.3, and 92.9% respectively. At 1-year post-sequential bilateral CI, the mean WRS, SIQ, and SIN score were 92.7, 98.7, and 97.7%, respectively. The improvement in bilateral CI speech scores compared with bimodal scores was statistically significant for WRS (pâ€Š=â€Š0.015). A ceiling effect limited the ability to detect further meaningful differences on speech perception testing. CONCLUSIONS:The bilateral CI condition demonstrates equivalent or slightly superior performance compared with the bimodal condition. Several non-speech benefits were elicited from parents as reasons for pursuing a second implant. Close monitoring of the residual acoustic hearing, inquiring about the perceived benefits provided by the HA, and early counseling regarding the potential for sequential bilateral CI are important aspects in determining if and when a second implant is indicated.