Recruiting

Cochlear Implants

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT07683689

Conditions

Deafness

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Everyday Clinical Listening Program (Control)

ENI-Based Experimental Program 1

ENI-Based Experimental Program 2

Study Details

Brief summary:

Cochlear implants are devices placed in the inner ear through surgery to help people with severe to profound hearing loss. While these devices work well overall, results vary widely from person to person. Many people with cochlear implants still have trouble understanding speech in noisy places and enjoying music.

This study looks at whether customizing the way a cochlear implant is programmed, based on the health of the hearing nerve in different areas of the ear, can help people understand speech better in noisy settings. The researchers will adjust or turn off certain electrodes in areas where the nerve appears weaker, then test whether this improves hearing compared to each person's everyday program. They will also examine whether giving people time to get used to the new program leads to better results.

Conditions

Deafness

Study ID

NCT07683689

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Jul 30, 2028

Anticipated

Primary completion date

Jul 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 - 80 years old
  • Native speakers of American English or Multilingual
  • Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer)
  • At least 6 months of listening experience with their cochlear implant, but could be recruited and consented prior.
  • Bilateral hearing loss

Exclusion Criteria:

  • Inability to provide informed consent
  • Lost their hearing prior to the age of language acquisition (3-4 years) but did not receive a cochlear implant until adulthood
  • Do not have age-appropriate speech perception testing from clinical visits or do not use their implant for oral communication
  • Have neurological disease
  • Have unmanageable facial nerve stimulation or pain as a result of their implant
  • Does not tolerate implant well
  • Unable to carry out the study protocol or tasks required in the study
  • Poor vision such that the subject cannot adequately perform the study tasks on the computer screen

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: All Participants (Within-Subjects Crossover)

This is a within-subjects study in which all enrolled participants receive every condition. Each participant's everyday clinical listening program serves as the control and is compared against two experimental sound-processing strategies based on electrode-neuron interface (ENI) estimates.

In the in-lab phase (Sub-Aim 1.1), all programs are compared acutely. In the take-home phase (Sub-Aim 1.2), participants complete a 12-week crossover consisting of 4 weeks with their clinical program followed by 4 weeks with each experimental strategy, with the order of programs randomized.

Interventions

Everyday Clinical Listening Program (Control)

The participant's standard clinical cochlear implant sound-processing program, as currently fit for everyday use. This serves as the within-subjects control condition and remains available as a backup throughout the take-home trial.

ENI-Based Experimental Program 1

An experimental cochlear implant sound-processing strategy that applies focused electrical fields for electrodes distant from regions of healthy neural tissue and/or deactivates channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model. Tested acutely in the lab and during one 4-week take-home interval.

ENI-Based Experimental Program 2

A second experimental cochlear implant sound-processing strategy applying focused electrical fields and/or channel deactivation based on electrode-neuron interface estimates, configured differently from Experimental Program 1. Tested acutely in the lab and during one 4-week take-home interval.

Primary outcome measure

  • Change in Sentence Recognition in Noise (Everyday Program vs. Experimental Programs), In-Lab [ Time Frame: Across a minimum of two in-lab sessions (each up to 3.5 hours) ]
  • Change in Vowel Identification (Everyday Program vs. Experimental Programs), In-Lab [ Time Frame: Across a minimum of two in-lab sessions (each up to 3.5 hours) ]

Central Contacts and Locations

Central contacts

Julie Arenberg, PhD, CCC-A

617-807-7904julie_arenberg@meei.harvard.edu

Locations

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02171

Contacts

Julie Arenberg, PhD, CCC-A

617-807-7904julie_arenberg@meei.harvard.edu

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • cochlear implant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.