Treatment for Single-Sided Deafness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Single-Sided Deafness+1 More
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a cochlear implant (a device that helps people with hearing loss hear) is safe and effective for people with unilateral hearing loss or single-sided deafness who are 5 years or older.

Eligible Conditions
  • Single-Sided Deafness
  • Unilateral Hearing Loss

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 36 months post-activation

36 months post-activation
Number of procedure and device related adverse events classified by type, frequency and severity.
pre-implantation, 12 months post-activation
Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.
Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations.
Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone.

Trial Safety

Trial Design

0 Treatment Group

60 Total Participants · 0 Treatment Group

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

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months post-activation

Who is running the clinical trial?

NAMSAOTHER
30 Previous Clinical Trials
13,447 Total Patients Enrolled
1 Trials studying Single-Sided Deafness
50 Patients Enrolled for Single-Sided Deafness
CochlearLead Sponsor
80 Previous Clinical Trials
5,730 Total Patients Enrolled
1 Trials studying Single-Sided Deafness
50 Patients Enrolled for Single-Sided Deafness
Jillian CrossonStudy DirectorCochlear

Eligibility Criteria

Age Any Age · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not previously experienced a current conventional treatment option for unilateral [SSD] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required.
You have a hearing loss that is severe enough to interfere with normal communication.
• Children 5 years to 17 years, 11 months (Group B) are eligible for treatment.
You speak English as a primary language.
You have severe sensorineural hearing loss.