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Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

N/A
Waitlist Available
Research Sponsored by Med-El Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* At least 18 years of age
* Is a cochlear implant candidate as deemed by the participating center
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 to 12 months
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study is to evaluate the impact of different audio processor frequency settings on performance outcomes in new cochlear implant users using electric-only stimulation in the implanted ear with normal hearing to moderately severe hearing loss in the opposite ear.

Eligible Conditions
  • Unilateral Hearing Loss
  • Sensorineural Hearing Loss
  • Cochlear Implants

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 to 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 to 7 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
Cochlear Implant Quality of Life - 35 Profile (CIQoL 35)
Percent correct on AzBio Sentences in Noise
Secondary study objectives
Cochlear Implant Quality of Life- 35 Profile (CIQoL35)
Decisional Regret Scale
Percent Correct on Az Bio Sentences in Noise
+4 more

Awards & Highlights

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

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Anatomy-Based Fitting 2Experimental Treatment1 Intervention
The audio processor frequency setting will be programmed with experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging.
Group II: Experimental Anatomy-Based Fitting 1Experimental Treatment1 Intervention
The audio processor frequency setting will be programmed using experimental settings for anatomy-based fitting using individual anatomical information obtained from analysis of post-operative imaging.
Group III: Default Clinical Frequency SettingActive Control1 Intervention
The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software
Group IV: Default Anatomy-Based FittingActive Control1 Intervention
The audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software

Find a Location

Who is running the clinical trial?

Med-El CorporationLead Sponsor
24 Previous Clinical Trials
1,004 Total Patients Enrolled
~33 spots leftby Apr 2028