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Electrode

CI632 Hearing Aid for Low-Frequency Hearing Loss

N/A
Waitlist Available
Research Sponsored by Cochlear
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years-of-age or older at the time of surgery
English spoken as a primary language
Must not have
Diagnosis of Auditory Neuropathy
Active middle-ear infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether the CI632 hearing aid can help adults with low-frequency residual hearing.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed for this device within the provided information, typical risks may include discomfort at the implant site, infection risk post-surgery, potential damage to residual natural hearing ability or changes in sound quality perceived through the implanted device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I primarily speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Auditory Neuropathy.
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I currently have a middle-ear infection.
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My inner ear structure may not allow full placement of a hearing device.
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I have had severe hearing loss for more than 20 years.
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I have hearing loss that is not due to ear damage.
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I am 70 years old or older at the time of my surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To characterize hearing performance of the CI632 in an adult population under expanded indications for use.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

CochlearLead Sponsor
93 Previous Clinical Trials
6,149 Total Patients Enrolled

Media Library

CI632 Slim Modiolar Electrode (Electrode) Clinical Trial Eligibility Overview. Trial Name: NCT04741009 — N/A
Low-Frequency Hearing Loss Research Study Groups: CI632 Slim Modiolar Electrode
Low-Frequency Hearing Loss Clinical Trial 2023: CI632 Slim Modiolar Electrode Highlights & Side Effects. Trial Name: NCT04741009 — N/A
CI632 Slim Modiolar Electrode (Electrode) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04741009 — N/A
~3 spots leftby Aug 2025
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