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Electrode

CI632 Hearing Aid for Low-Frequency Hearing Loss

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
89 Previous Clinical Trials
6,016 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible to join this research project?

"This clinical trial is inviting a cohort of 15 individuals, aged 18 to 70 years old who possess low-frequency residual hearing. Other eligibility criteria include being 18 or older at the time of surgery, having a 500 Hz threshold ≤ 50 dB HL and 2000–8000 Hz PTA ≥ 65 dB HL in their intended implant ear, 0.5k/1k/2k Hz PTA > 30dB HL in the opposite ear, CNC word recognition scores (combined from two lists) no higher than 60% on their intended implant side and 80% on the other side; primary English speaking; and demonstrating willingness to provide written consent"

Answered by AI

Is this research initiative still accepting new participants?

"The clinical trial is still open for enrollment, as per the information available on clinicialtrials.gov. The study was first published in December 2021 and has recently been updated in September 2022."

Answered by AI

How many participants have been recruited for the trial thus far?

"Affirmative, current information on clinicaltrials.gov confirms that this trial is actively recruiting participants and was initially posted on December 16th 2021. 15 people are needed to be recruited from 3 distinct medical centres."

Answered by AI

Does this research program accept volunteers aged 50 and older?

"The age criteria for this research stipulates that participants must be at least 18 years of age and not older than 70 years."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
What site did they apply to?
Georgetown University
Midwest Ear Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I need help hearing. Hearing aids don’t help.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Midwest Ear Institute: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing
2021. "Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04741009.
All > Sensorineural Hearing Loss > Hearing Loss
~0 spots leftby May 2024
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