CI632 Hearing Aid for Low-Frequency Hearing Loss

Recruiting at 4 trial locations

Overseen By Michael Hoa, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Disqualifiers: Age over 70, Cochlear anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

Is the CI632 Slim Modiolar Electrode generally safe for humans?

The CI532 Slim Modiolar Electrode, similar to the CI632, is designed to minimize trauma to the cochlea (inner ear) during insertion, which suggests a focus on safety. Studies have reported on its use in humans, indicating it is generally safe, though specific safety data for the CI632 is not detailed in the available research. ^{1 2 3 4 5}

How is the CI632 Slim Modiolar Electrode treatment unique for low-frequency hearing loss?

The CI632 Slim Modiolar Electrode is unique because it is designed to be placed close to the auditory nerve, which may help preserve hearing and improve sound quality by reducing trauma to the cochlea (the inner ear structure responsible for hearing) during insertion. ^{1 2 3 4 6}

Eligibility Criteria

Adults aged 18+ with low-frequency hearing loss who speak English and can consent. They must have a specific range of hearing loss in both ears, as measured by certain tests, and not exceed a word recognition score. Excluded are those over 70, with long-term or early-onset severe hearing loss, other ear problems, medical/psychological surgery risks, unrealistic expectations about the device's benefits/risks, additional handicaps affecting test participation, current involvement in another trial with drugs/devices or cochlear anomalies.

Inclusion Criteria

I am 18 years old or older.

Your hearing loss in the ear to be implanted is too severe for this study.

Your hearing in the other ear is worse than a certain level when tested at specific frequencies.

Exclusion Criteria

You work for Cochlear or a company that helps Cochlear with this study.

I have been diagnosed with Auditory Neuropathy.

Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CI632 implant and undergo audiometry and speech perception testing

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Treatment Details

Interventions

• CI632 Slim Modiolar Electrode

Trial Overview The study is testing the CI632 Slim Modiolar Electrode's performance on adults with residual low-frequency hearing. It aims to assess how well participants can hear (audiometry) and understand speech (speech perception) after implantation. The trial will include only 15 participants meeting strict criteria for their level of hearing impairment.

Participant Groups

Group I: CI632 Slim Modiolar Electrode Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Cochlear

Lead Sponsor

Trials

96

Recruited

6,300+

Headquarters

Sydney, Australia

Dig Howitt

Cochlear

Chief Executive Officer since 2018

BE (Hons), MBA

Michael del Prado

Cochlear

Chief Medical Officer since 2022

MD, MSc, FRACP, FAAHMS, FAICD

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of Perimodiolar Electrodes: Imaging and Electrophysiological Outcomes. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Speech Recognition Outcomes in Adults With Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Slim Modiolar Electrode Placement in Candidates for Electroacoustic Stimulation. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Objective, audiological and quality of life measures with the CI532 slim modiolar electrode. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of Clarion electrode design on mapping levels in children. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Early Outcomes With a Slim, Modiolar Cochlear Implant Electrode Array. [2022]