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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 belowSelect...
I am 18 years old or older.
Select...
I primarily speak English.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with Auditory Neuropathy.
Select...
I currently have a middle-ear infection.
Select...
My inner ear structure may not allow full placement of a hearing device.
Select...
I have had severe hearing loss for more than 20 years.
Select...
I have hearing loss that is not due to ear damage.
Select...
I am 70 years old or older at the time of my surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
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
6,124 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You work for Cochlear or a company that helps Cochlear with this study.I am 18 years old or older.I have been diagnosed with Auditory Neuropathy.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.I currently have a middle-ear infection.You have severe hearing loss at multiple frequencies in the ear where the implant would be placed.My inner ear structure may not allow full placement of a hearing device.Your ability to understand words is very low in the ear that needs the implant and is also reduced in the other ear.I have had severe hearing loss for more than 20 years.I experienced hearing loss before I was 5 years old.I have hearing loss that is not due to ear damage.I have no health or mental conditions that prevent me from having surgery.I am 70 years old or older at the time of my surgery.I primarily speak English.
Research Study Groups:
This trial has the following groups:- Group 1: CI632 Slim Modiolar Electrode
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.