Reviewed by Michael Gill, B. Sc.
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Phase-Based Progress Estimates
1
Effectiveness
1
Safety

Experimentalfor Sensorineural Hearing Loss, Bilateral

18+
All Sexes
Hearing loss is a major cause of disability that affects over 48 million Americans. There are currently no medications used to treat sensorineural hearing loss. Cochlear implants can significantly restore hearing in adults with moderate to profound sensorineural hearing loss, but their utility is limited by the wide variability in hearing outcomes. Differences in cochlear implant outcomes may be explained by neuroplasticity, as neural networks must reorganize to process the new auditory information provided by the implant. Therefore, the investigators predict that cholinergic enhancement with donepezil (an acetylcholinesterase inhibitor) may facilitate cortical reorganization after cochlear implantation, leading to functional improvements in speech recognition and cognition. In this randomized, double-blind controlled trial, the investigators aim to assess the effects of donepezil on speech recognition, cortical plasticity, and cognition. Participants will start daily treatment with either donepezil 5 mg or placebo at the time of cochlear implant activation. Participants will be followed longitudinally at 1 month, 3 months, and 6 months post-implantation. The findings from this study will provide important insight into the mechanisms of hearing restoration and could potentially improve hearing and cognitive outcomes for future cochlear implant users.
Phase < 1
Recruiting
Vanderbilt University Medical CenterRené Gifford, PhD
23 Cochlear Implant Clinical Trials Near Me
Top Cities for Cochlear Implant Clinical Trials
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Los Angeles
6Active Trials
Keck School of Medicine of USCTop Active Site
Most Recent Cochlear Implant Clinical Trials

Individuals with bilateral sensorineural hearing loss have benefited from cochlear implant (CI) technology, which transmits sound signals directly to the brain instead of the damaged inner ear. In the United States, the Food and Drug Administration (FDA) has just recently authorized the use of cochlear implants to treat single-sided deafness.

What Are Cochlear Implant Clinical Trials?

A major goal of many Cochlear Implant Clinical Trials is to better understand the effects of abnormal auditory input on the brainstem and the effects of the brain on activity in the ear via efferent feedback loops.

Research at the Johns Hopkins Cochlear Implant Center focuses on the interaction between environmental noise and various forms of hearing loss (including hereditary, conductive, noise-induced, age-related, and traumatic brain injury-related loss of hearing).

Why is Cochlear Implant Treatment Studied in Clinical Trials?

The relationship between central auditory processing deficiencies, tinnitus, and hyperacusis, and the plastic changes in the brain that compensate for some parts of altered auditory input, are of particular interest. Having a firm grasp on these shifts will allow for the development of more effective therapy tactics and the discovery of novel treatment targets.

How Does Cochlear Implant Treatment Work?

Hearing aids and cochlear implants are two very different types of medical technology. A cochlear implant offers the feeling of sound by stimulating the auditory nerve directly, rather than through amplification, which aids a person with residual hearing ability.

Those who are profoundly hard of hearing or deaf can experience the sense of sound with a cochlear implant by avoiding the damaged inner ear, but this does not mean that the implant will cure or restore their hearing.

Unlike hearing aids, they require surgical implantation.

Candidates for a cochlear implant

Children

Cochlear implants can be given to children as young as 12 months who have been diagnosed with profound hearing loss. A child’s eligibility is determined by whether they meet the following criteria:

  • Get little benefit from hearing aids.
  • Have no preexisting conditions that would make surgery risky.
  • Want to join the hearing community and interact with others through listening, talking, and speechreading.

Adults

More and more adults are opting to have cochlear implants. Loss of hearing at any point in adulthood, including after language acquisition, does not disqualify a person from receiving a cochlear implant. Success rates with cochlear implants are higher among adults who acquired language before to deafness (prelingually deafened) than among those who did not acquire language prior to deafness (prelingually deafened).

In most cases, persons who match one of the following requirements are good candidates for implants:

  • Have a hearing loss that is severe or profound in both ears.
  • Use hearing aids ineffectively or not at all.
  • Lack any preexisting conditions that might necessitate postoperative care.
  • Want to join the hearing community and interact with others through listening, talking, and speechreading.

Who Are The Key Opinion Leaders On Cochlear Implant Clinical Trial Research?

Dr. Nabil Simaan of Vanderbilt University is a Professor of Mechanical Engineering, Computer Science, and Otolaryngology.

Researchers Anthony Hogan, Merril Stewart, and Ellen Giles have made significant contributions to our understanding of how persons with cochlear implants fare in the workplace.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

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