Actively Recruiting

Phase Not Applicable
Age: 3Months +
All Genders
Healthy Volunteers
ID05867173

Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners

Led by Massachusetts Eye and Ear Infirmary · Updated on 2025-11-26

200

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Massachusetts Eye and Ear Infirmary

Lead Sponsor

B

Boston Children's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how cochlear implants affect the developing hearing system in children and adults with severe hearing loss. The study aims to better understand how these implants influence auditory development, test new methods for programming cochlear implants tailored to individual listeners, and examine how long it takes users to adjust to new implant settings over both short and long periods. This research hopes to improve hearing outcomes by advancing knowledge about cochlear implant stimulation and listener adaptation. Participants will be assigned randomly to one of three groups: listening with an experimental cochlear implant processing strategy, listening with their usual clinical cochlear implant program, or listening with an experimental program similar to their clinical one. The experimental processing uses a dynamic focusing strategy programmed into a speech processor. The study includes both children and adults who use cochlear implants made by specific manufacturers. During the study, participants will undergo assessments of auditory function including electrical responses, behavioral measures of hearing resolution, and speech perception tests at baseline and weekly for ten weeks after intervention. Researchers will also collect data on vocabulary development, hearing quality of life, and sound quality perception. The study includes safety monitoring and follow-up through these repeated measures, with total participation lasting at least 10 weeks after the intervention.

CONDITIONS

Brief Title

Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

Who Can Participate

Age: 3Months +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults at least 18 years old
  • Children at least 3 months old
  • Native speakers of American English
  • Use a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL
  • Ability to follow study procedures and complete required tasks
Not Eligible

You will not qualify if you...

  • Inability to provide informed consent
  • Does not meet specific study criteria such as age of hearing loss onset, age of implantation, duration of deafness, or number of active electrodes
  • Unable to carry out study protocol or required tasks
  • For normal hearing subjects: hearing loss or significant hearing issues
  • Inability to provide informed consent for normal hearing subjects

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 10 weeks

Participants listen with an experimental cochlear implant processing strategy or their own clinical processor according to group assignment.

Weekly visits for 10 weeks

Trial Site Locations

Total: 2 locations

1

Mass Eye and Ear

Boston, Massachusetts, United States, 02114

Actively Recruiting

2

Boston Children's Hospital

Waltham, Massachusetts, United States, 02453

Actively Recruiting

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Research Team

J

Julie Arenberg

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

3

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