Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

Last updated: November 20, 2024
Sponsor: Massachusetts Eye and Ear Infirmary
Overall Status: Active - Recruiting

Phase

N/A

Condition

Deafness

Treatment

Detection Threshold Testing

Telemetry Recordings

Montreal Cognitive Assessment (MoCA)

Clinical Study ID

NCT05867173
MGB_2019P000239
  • Ages > 6
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria

  • Adult at least 18 years old

  • Native speakers of American English

  • Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I ornewer), Cochlear, or MED-EL

CHILDREN Inclusion Criteria

  • Children at least 6 months old

  • Native speakers of American English

  • Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I ornewer), Cochlear, or MED-EL

  • For both children and adults with a cochlear implant, some study criteria mightpertain to a subset of subjects, such as a specific age at which the subjectsdeveloped a hearing loss, or was implanted.

Exclusion

Exclusion Criteria:

Exclusion for all Cochlear Implant Subjects:

  • Inability to provide informed consent

  • Does not meet the inclusion criteria for a specific study protocol, such as age ofonset of hearing loss, age of cochlear implantation, duration of deafness, number ofactive electrodes in the cochlear implant device

  • Unable to carry out the study protocol or tasks required in the study

Exclusion for all Normal Hearing Subjects:

  • Inability to provide informed consent

  • Hearing loss, or significant history of hearing related issues

  • Unable to carry out the study protocol or tasks required in the study

Study Design

Total Participants: 200
Treatment Group(s): 6
Primary Treatment: Detection Threshold Testing
Phase:
Study Start date:
September 16, 2022
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Mass Eye and Ear

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Mass General Brigham

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Waltham, Massachusetts 02453
    United States

    Active - Recruiting

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