Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness

Study Overview
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Brief Summary
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The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).

Official Title
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Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness

Conditions
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Hearing Loss, Partial Deafness, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases

Intervention / Treatment
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* Device: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode
* Device: EAS sound processor


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Newly Implanted Group: Ability to provide informed consent No previous cochlear implant experience in either ear 18 years of age or older Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000, 4,000, and 8,000 Hz) in the ear to be implanted Aided CNC word recognition score up to 50% in ear to be implanted Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear Aided CNC word recognition score up to 80% in the contralateral ear English language proficiency Willingness to use an ear-level sound processor postoperatively for the duration of the study trial Willingness to participate in all scheduled procedures outlined in the protocol Exclusion Criteria: Newly Implanted Group: Preoperative audiometric conductive overlay of 15 dB or greater at two frequencies or more in range of 500-1000 Hz in the ear to be implanted Congenital hearing loss (for purpose of this study, onset prior to age 2 years*). *Based on critical period for speech and language development Duration greater than 30 years of severe-to-profound high-frequency hearing loss Cochlear malformation or obstruction that would preclude full insertion of electrode array in the ear to be implanted Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear Active middle-ear disease/infection in the ear to be implanted Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator EAS Fitting Inclusion Criteria: Newly Implanted and Existing Implanted Groups Ability to provide informed consent 18 years of age or older, unilaterally implanted with HiRes90K™ Advantage cochlear implant with HiFocus™ Mid-Scala electrode and fit with an ear-level sound processor (i.e. Naída family device) Postoperative unaided low frequency audiometric hearing thresholds in the treated ear up to 80 dB HL for at least one frequency from 125 - 1000 Hz English Language Proficiency Willingness to participate in all scheduled procedures outlined in the study protocol EAS Fitting Exclusion Criteria: Newly Implanted and Existing Implanted Groups Unilaterally implanted with HiRes 90K™ Advantage cochlear implant with HiFocus™ Helix® and HiFocus™ 1j electrode Exclusive use of a body worn external sound processor Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear Postoperative unaided low frequency audiometric hearing thresholds in the treated ear exceeding 80 dB HL at each frequency from 125 - 1000 Hz Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The two main arms are conducted in parallel. The third arm is optional for subjects who complete either of the two main arms using the EAS sound processor.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Newly Implanted Group<br>HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor. | Device: HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode<br>* HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).<br>Device: EAS sound processor<br>* Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.<br>|
| Experimental: Existing Implanted Group<br>Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. | Device: EAS sound processor<br>* Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.<br>|
| Experimental: EAS Extended Use Arm<br>Adults who are unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness and completed the 12 Month visit using the EAS sound processor in either the Newly Implanted Group or Existing Implanted Group. | Device: EAS sound processor<br>* Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unaided pure-tone hearing threshold measurements | Unaided pure tone hearing threshold measurement in the implanted ear 3 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison) | Three months | 
| Speech perception testing | Speech perception testing (in quiet and noise) in the treated ear compared to pre-implant speech perception testing (in quiet and noise) | Up to 19 months | 
| Questionnaire data | Speech, Spatial Qualities (SSQ) questionnaire, Abbreviated Profile of Hearing Aid Benefits (APHAB) and Sponsored Development questionnaires post-implant compared to pre-implant condition | Up to 19 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cochlear Implant, HiRes™ 90K Advantage implant, Cochlear Implantation, HiFocus™ Mid-Scala electrode, Listening Benefits, Adults, Cochlear Implant Benefit, Electrical Stimulation, Electro-Acoustic Stimulation (EAS)