Treatment for Hearing Loss, Cochlear

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hearing Loss, Cochlear+3 More
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and effectiveness of cochlear implants for those with single-sided deafness or asymmetric hearing loss.

Eligible Conditions
  • Hearing Loss, Cochlear
  • Deafness, Unilateral

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Three years (36 months) post implantation

Month 36
Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation
Long term performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through three years (36 months) post implantation
Long term safety will be evaluated for all study subjects through three (36 months) years post implantation
Long term subjective benefit of the Cochlear Implant System will be assessed through three years (36 months) post implantation
Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation

Trial Safety

Safety Progress

1 of 3

Trial Design

0 Treatment Group

65 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · N/A

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: three years (36 months) post implantation

Who is running the clinical trial?

Med-El CorporationLead Sponsor
19 Previous Clinical Trials
655 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Someone who has previously used a CROS hearing aid, BI-CROS hearing aid, bone conduction hearing aid, or traditional hearing aid is likely to be appropriate for a CROS hearing aid
A person has normal hearing or mild to moderate hearing loss if their pure-tone average is 55 dB or less.
This means that a person must be at least five years old when they get the implant.
, was determined in 14 patients (5.5% of total) 14 patients had a unilateral profound hearing loss, meaning that their average hearing loss at 500, 1000, 2000, and 4000 Hz was 90 dB or greater.
The word recognition in the ear to be implanted will have a CNC word score of 5% or less in quiet.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: October 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
North Carolina100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of North Carolina100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References