15 Participants Needed

CI632 Hearing Aid for Low-Frequency Hearing Loss

Recruiting at 4 trial locations
LC
PR
MH
Overseen ByMichael Hoa, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cochlear
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

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.12346

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.

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

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.
Willing and able to provide written informed consent
See 2 more

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
See 12 more

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
1Treatment groups
Experimental Treatment
Group I: CI632 Slim Modiolar ElectrodeExperimental Treatment1 Intervention

Find a Clinic Near You

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

Comparison of Perimodiolar Electrodes: Imaging and Electrophysiological Outcomes. [2021]
Speech Recognition Outcomes in Adults With Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays. [2022]
Slim Modiolar Electrode Placement in Candidates for Electroacoustic Stimulation. [2023]
Objective, audiological and quality of life measures with the CI532 slim modiolar electrode. [2022]
Effects of Clarion electrode design on mapping levels in children. [2017]
Early Outcomes With a Slim, Modiolar Cochlear Implant Electrode Array. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security