Customizing cochlear implant programming based on inner ear nerve health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will evaluate whether adjusting or turning off certain cochlear implant electrodes, guided by a model of nerve health, improves speech-in-noise performance compared with the participant’s usual program. The study also explores whether giving users time to adapt to the new programming yields further benefits. Participants with severe to profound hearing loss and a qualifying cochlear implant will be enrolled and randomized to either their everyday program or two variations of an ENI-based experimental program. Outcomes will focus on speech understanding in noise and overall listening experience. The trial is conducted at Massachusetts Eye and Ear Infirmary with adults aged 18 to 80 who use Advanced Bionics implants and have at least 6 months of listening experience.

Why it matters

Who can join: the full rules

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

Where it's running

• Massachusetts Eye and Ear
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Julie Arenberg, PhD, CCC-A — Massachusetts Eye and Ear
• Study coordinator: Julie Arenberg, PhD, CCC-A
• Email: julie_arenberg@meei.harvard.edu
• Phone: 617-807-7904

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Early hearing loss detection in a memory clinic

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• Understanding how cochlear implants affect hearing in children and adults

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  Recruiting at 2 sites Massachusetts Eye and Ear Infirmary · Boston, Massachusetts and 1 other locations · NCT05867173

• Investigating how cochlear and auditory brainstem implants affect hearing processing

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  Recruiting NYU Langone Health · New York, New York · NCT05810220

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.