Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
Key facts
- Who runs it
- Med-El Corporation
- Where
- Chapel Hill, Durham, Iowa City, Kansas City, Philadelphia, and Portland, United StatesSee the 6 sites
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 50 people, planned
- Started
- 10 Nov 2025
- Expected to end
- Oct 2028
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Programming of cochlear implant audio processor frequency settings
- Record updated
- 27 March 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who cannot take part
- Subjects who receive a cochlear implant in the contralateral ear prior to the 12-month interval
- Subjects who do not meet one or more of the above-mentioned inclusion criteria are excluded from the study
- Subjects required to use a hearing aid per inclusion criteria who stop use of a hearing aid in the contralateral ear will be withdrawn at the time of discontinued hearing aid use
Other criteria
- At least 18 years of age
- Is a cochlear implant candidate as deemed by the participating center
- Implanted (or to be implanted) unilaterally with a MED-EL cochlear implant with moderately severe or better acoustic hearing in the contralateral ear
- For patients who are already implanted, device activation must have occurred within 2 weeks of enrollment
- Patients with moderate contralateral hearing loss or greater must utilize a hearing aid in the contralateral ear
- Programmed with electric-only stimulation in the implanted ear
- The ear to be implanted, acoustic hearing thresholds must be no better than 50 dBHL at 250 Hz and 65 dBHL at 500 Hz
- Post-operative CT scan allows for completion of OTOPLAN analysis
- ABF settings possible at defaults in clinical programming software
- Minimum of 10 active electrodes at activation
- Programmed using a Fine Structure coding strategy
- English is the primary language
- Willing and able to comply with all scheduled procedures as defined in the protocol
Where in United States
- University of North CarolinaChapel Hill, United StatesNo longer taking part
- MED-EL CorporationDurham, United StatesNo longer taking part
- University of IowaIowa City, United StatesNo longer taking part
- University of Kansas Medical CenterKansas City, United StatesNo longer taking part
- Thomas Jefferson UniversityPhiladelphia, United StatesNo longer taking part
- Oregon Health and Science UniversityPortland, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Default Clinical Frequency SettingExisting treatment, for comparison
The audio processor frequency setting will be programmed based on current frequency defaults in the clinical programming software
Treatment: Programming of cochlear implant audio processor frequency settings
- Default Anatomy-Based FittingExisting treatment, for comparison
The audio processor frequency setting will be programmed based on current anatomy-based fitting frequency defaults in the clinical programming software
Treatment: Programming of cochlear implant audio processor frequency settings
- Experimental Anatomy-Based Fitting 1Treatment being tested
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.
Treatment: Programming of cochlear implant audio processor frequency settings
- Experimental Anatomy-Based Fitting 2Treatment being tested
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.
Treatment: Programming of cochlear implant audio processor frequency settings
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Impact of Anatomy-Based Frequency (ABF) Allocations on Early Performance Outcomes in MED-EL Cochlear Implant Recipients
- Record updated
- 27 March 2026