CompletedNot Applicable

Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss

United States24 participantsStarted 2016-11-07

Plain-language summary

The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: General Requirements: * Ability to provide Informed Consent * 18 years of age or older * English language proficiency * Willingness to participate in all scheduled procedures outlined in the study investigational plan * Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study Ear to be Implanted: * Severe-to-profound sensorineural hearing loss (\> 70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz * CNC word recognition score ≤30% (tested in subject's everyday listening condition for that ear) * Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) \>3 months and ≤10 years in the ear to be implanted only Contralateral (non-implanted) ear: * Up to a moderate sensorineural hearing loss (\<70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz * CNC word recognition score \>30% (tested in subject's everyday listening condition for that ear) Exclusion Criteria: * Previous experience with a cochlear implant * Cochlear malformation or obstruction (i.e. ossification) 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 * Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralater…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)

Timeframe: Baseline and Twelve months

Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)

Timeframe: Baseline and Twelve months

Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front

Timeframe: Baseline and Twelve months

Change in Lateralization Ability Testing (Bilateral Listening Condition)

Timeframe: Baseline and Twelve months

Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear

Timeframe: Baseline to Twelve Months

Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.

Timeframe: Baseline to Twelve Months

Trial details

NCT IDNCT02811549

SponsorAdvanced Bionics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-25

Results submitted2022-12-02

View on ClinicalTrials.gov More Hearing Loss trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)

Timeframe: Baseline and Twelve months

Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)

Timeframe: Baseline and Twelve months

Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front

Timeframe: Baseline and Twelve months

Change in Lateralization Ability Testing (Bilateral Listening Condition)

Timeframe: Baseline and Twelve months

Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear

Timeframe: Baseline to Twelve Months

Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.

Timeframe: Baseline to Twelve Months