Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

NCT05867173 | Recruiting

• 1 other identifier: MGB_2019P000239
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Deafness

Outcome Measures

Primary Outcomes (7)

• Slopes of the spread of excitation of the electrically evoked compound action potential responses

  Responses of the auditory nerve can be measured directly from the cochlear implant using software developed by the implant manufacturer. By changing the distance between two electrodes, we can quantify the spread of activation in the cochlea.

  Baseline

• Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.

  A behavioral test designed to measure how spectral information is processed in the auditory system. By changing the relationship between a masker and target signal, we can assess resolution.

  Baseline

• Changes in vowel identification scores

  Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.

  Baseline and weekly for 10 weeks after the intervention

• Changes in sentence recognition scores

  Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing.

  Baseline and weekly for 10 weeks after the intervention

• Changes in speech-gap detection thresholds

  Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing.

  Baseline and weekly for 10 weeks after the intervention

• Changes in phoneme discrimination scores

  Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing.

  Baseline and weekly for 10 weeks after the intervention

• Changes in time (weeks) with programming strategy

  Outcome measures will be obtained at weekly intervals during the intervention, and the weekly collection of those measures will be analyzed.

  Baseline and weekly for 10 weeks after the intervention

Secondary Outcomes (5)

• Age

  Age at baseline

• Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores

  Baseline, and weekly for 10 weeks after the intervention

• Macarthur-Bates vocabulary inventory scores

  Baseline, and weekly for 10 weeks after the intervention

• Hearing quality of life (HEARQL) scores

  Baseline, 5 weeks, and 10 weeks after the intervention

• Sound quality questionnaire

  Baseline and weekly for 10 weeks after the intervention

Study Arms (3)

Performance Assessed with Experimental Sound Processing Strategy

EXPERIMENTAL

Patients listening to experimental cochlear implant processing strategy.

Other: Experimental Speech Processing Strategy

Control

NO INTERVENTION

Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation).

Experimental Control

SHAM COMPARATOR

Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program.

Other: Experimental Speech Processing Strategy

Interventions

Experimental Speech Processing Strategy OTHER

Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.

Experimental Control; Performance Assessed with Experimental Sound Processing Strategy

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult at least 18 years old
• Native speakers of American English
• Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL
• Children at least 3 months old
• Native speakers of American English
• Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL
• For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted.

You may not qualify if:

• Inability to provide informed consent
• Unable to carry out the study protocol or tasks required in the study
• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• Boston Children's Hospital: collaborator
• University of Washington: collaborator

Study Sites (2)

Mass Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

Boston Children's Hospital

Waltham, Massachusetts, 02453, United States

RECRUITING

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Arenberg

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Arenberg

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Education

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: May 19, 2023
• Study Start: September 16, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

US (2)