Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.

Official Title
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Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode

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

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No previous cochlear implant experience 18 years of age or older Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL 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, 4,000, and 8,000 Hz) in the ear to be implanted Aided monosyllabic word score of 10-50% in the ear to be implanted Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL 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, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear English language proficiency Willingness to participate in all scheduled procedures outlined in the protocol Exclusion Criteria: Previous inner ear surgery Cochlear malformation or obstruction that would preclude full insertion of electrode array Presence of additional disabilities that would prevent or interfere with participation in the required study procedures Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures Evidence of central auditory lesion or compromised auditory nerve

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HiRes90K™ Advantage Cochlear Implant<br>HiRes90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with a moderate level of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies. | Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array | Unaided low-frequency acoustic hearing thresholds (under earphones) in the implanted ear one month after device activation will be compared to baseline (pre-implant) thresholds in the same ear for audiometric frequencies 125-1000Hz. Threshold changes from baseline will be calculated as: Complete preservation of hearing: threshold shift ≤ 15 dB Partial preservation of hearing: threshold shift ≥ 16 dB with measurable thresholds No preservation of hearing: no measurable thresholds at ≤ 80 dB HL | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array | Word recognition scores in quiet in the implanted ear one month after device activation compared to pre-implant score with a hearing aid | One month | 

 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, HiRes Fidelity 120™, Electrical Stimulation