Objective: This study investigated the safety and efficacy of remote programming of cochlear implants. Study Design: Single-subject design Setting: Four North American clinical sites Patients: Forty cochlear implant recipients aged 12 years or older Intervention: Subjects had their cochlear implants programmed at a location that was remote from their audiologist using telecommunication with and without the support of a facilitator. Main Outcome Measures: Consonant-Nucleus-Consonant (CNC) word scores and the Speech, Spatial, and Qualities of Hearing Scale-C (SSQ-C) were compared using the subject's in-office MAP (program) and MAPs programmed remotely with and without the assistance of a facilitator. Additional subjective preference data were gathered from subjects and audiologists via questionnaires. Results: MAPs programmed via the three different models did not yield significantly different group mean CNC word scores. No device/procedure-related adverse events occurred. SSQ-C questionnaire results indicated that recipients received similar subjective benefit from familiar in-office, remote-facilitated, and remote-unassisted MAPs. Conclusions: Remote programming is an effective means of cochlear implant service delivery. The practice was approved by the FDA on November 17, 2017 supported by the results of this study.
ObjectivesTo evaluate the utility of intracochlear electrocochleography (ECochG) monitoring during cochlear implant (CI) surgery on postoperative hearing preservation.Study DesignProspective, randomized clinical trial.SettingTen high-volume, tertiary care CI centers.PatientsAdult patients with sensorineural hearing loss meeting the CI criteria who selected an Advanced Bionics CI.MethodsPatients were randomized to CI surgery either with audible ECochG monitoring available to the surgeon during electrode insertion or without ECochG monitoring. Hearing preservation was determined by comparing preoperative unaided low-frequency (125-, 250-, and 500-Hz) pure-tone average (LF-PTA) to postoperative LF-PTA at CI activation. Pre- and post-CI computed tomography was used to determine electrode scalar location and electrode translocation.ResultsEighty-five adult CI candidates were enrolled. The mean (standard deviation [SD]) unaided preoperative LF-PTA across the sample was 54 (17) dB HL. For the whole sample, hearing preservation was “good” (i.e., LF-PTA change 0–15 dB) in 34.5%, “fair” (i.e., LF-PTA change >15–29 dB) in 22.5%, and “poor” (i.e., LF-PTA change ≥30 dB) in 43%. For patients randomized to ECochG “on,” mean (SD) LF-PTA change was 27 (20) dB compared with 27 (23) dB for patients randomized to ECochG “off” (p = 0.89). Seven percent of patients, all of whom were randomized to ECochG off, showed electrode translocation from the scala tympani into the scala vestibuli.ConclusionsAlthough intracochlear ECochG during CI surgery has important prognostic utility, our data did not show significantly better hearing preservation in patients randomized to ECochG “on” compared with ECochG “off.”
Objective: To determine postcochlear implantation performance for patients qualifying on preimplant testing in noise. Study design: Retrospective chart review of cochlear implant recipients. Main Outcome Measure: Performance on word and sentence testing in the implanted ear and bimodal condition were compared between pre-and postimplantation time points. Results: At 2-years postimplantation, CNC testing in quiet in the implanted ear improved from an average percent correct score of 14.0 AE 12.1% to 54.9 AE 14.8% (n ¼ 20, p < 0.0001, d ¼ 3.0) for those qualifying at þ8, and from 23.4 AE 15.6% to 55.5 AE 19.4% (n ¼ 28, p < 0.0001, d ¼ 1.8) for those qualifying at þ5. Likewise, AzBio in quiet in the implanted ear improved from an average % correct score of 19.9 AE 16.0% to 75.1 AE 11.8% (n ¼ 20, p < 0.0001, d ¼ 4.0) for those qualifying at þ8, and from 46.2 AE 21.7% to 74.1 AE 21.3% (n ¼ 27, p < 0.0001, d ¼ 1.4) for those qualify-ing at þ5. CNC and AzBio performance in quiet in the bimodal condition also improved with those qualifying at þ8 and þ5 having similar average scores at 2-years post activation. For those qualifying at þ8, performance improved on CNC and AzBio in the implanted ear in 95% of patients and in the bimodal condition in 89% of patients. The proportion of patients improving on both tests for those qualifying at þ5 at 2 years was 85% in the implanted ear, and 72% in the bimodal condition. Conclusion:The majority of patients qualifying for cochlear implantation with the addition of noise showed improved speech perception in quiet. These data provide useful counseling tools for patients considering cochlear implantation who do not meet traditional eligibility requirements when tested in quiet.
There are many barriers that prevent the use of traditional acoustic amplification including anatomic and medical conditions and patient preference. Implantable hearing devices typically avoid the use of the ear canal and can overcome many of these barriers. Current options include partially and fully implantable devices, devices that make use of bone conduction, devices that directly couple to the ossicular chain, and those that provide more direct cochlear stimulation. This article reviews the major devices that are currently available or in development providing information regarding clinical indications, device components, the general surgical procedure, and typical outcomes. This review should help the clinician understand device options to fit specific patient anatomy and amplification needs.
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