Impact of Anatomy-Based Cochlear Implant Programming on Early Performance

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Med-El Corporation
Study ID
NCT06734039
Status
Enrolling By Invitation

Conditions

  • Asymmetric Hearing Loss
  • Cochlear Implants
  • Hearing Loss, Sensorineural
  • Hearing Loss, Unilateral
  • Single-Sided Deafness (SSD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Programming of cochlear implant audio processor frequency settings — DEVICE
    Cochlear implant audio processor frequency settings will be adjusted within the clinical programming software

Study Details

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.

Key Dates

Start date
Nov 10, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Default Clinical Frequency Setting
    The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software
  • Active Comparator: Default Anatomy-Based Fitting
    The audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software
  • Experimental: Experimental Anatomy-Based Fitting 1
    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.
  • Experimental: Experimental Anatomy-Based Fitting 2
    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.

Primary Outcome Measure

Percent correct on AzBio Sentences in Noise [ Time Frame: 3 to 7 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242-
University of Kansas Medical CenterKansas CityKansas66160-
University of North CarolinaChapel HillNorth Carolina27599-
MED-EL CorporationDurhamNorth Carolina27516-
Oregon Health and Science UniversityPortlandOregon97239-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Find similar trials in Iowa City, IA

By research site
University of Iowa· Iowa City, IAUniversity of Kansas Medical Center· Kansas City, KSUniversity of North Carolina· Chapel Hill, NCMED-EL Corporation· Durham, NCOregon Health and Science University· Portland, ORThomas Jefferson University· Philadelphia, PA

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