Recruiting

Cochlear Implant

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT05867173

Conditions

Deafness

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Experimental Speech Processing Strategy

Study Details

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

Study ID

NCT05867173

Start date

Sep 16, 2022

Status verified date

Nov, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 or newer), Cochlear, or MED-EL

CHILDREN Inclusion Criteria

  • 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.

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 of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active 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

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Performance Assessed with Experimental Sound Processing Strategy

Patients listening to experimental cochlear implant processing strategy.

no intervention: Control

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

sham comparator: Experimental Control

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

Interventions

Experimental Speech Processing Strategy

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

Primary outcome measure

  • Slopes of the spread of excitation of the electrically evoked compound action potential responses [ Time Frame: Baseline ]
  • Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves. [ Time Frame: Baseline ]
  • Changes in vowel identification scores [ Time Frame: Baseline and weekly for 10 weeks after the intervention ]
  • Changes in sentence recognition scores [ Time Frame: Baseline and weekly for 10 weeks after the intervention ]
  • Changes in speech-gap detection thresholds [ Time Frame: Baseline and weekly for 10 weeks after the intervention ]
  • Changes in phoneme discrimination scores [ Time Frame: Baseline and weekly for 10 weeks after the intervention ]
  • Changes in time (weeks) with programming strategy [ Time Frame: Baseline and weekly for 10 weeks after the intervention ]

Central Contacts and Locations

Central contacts

Julie Arenberg

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

Locations

Mass Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Julie Arenberg

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

Principal Investigator:

Julie Arenberg

Boston Children's Hospital

Recruiting

Waltham, Massachusetts, United States, 02453

Contacts

Amanda Griffin

781-216-3657amanda.griffin@childrens.harvard.edu

Principal Investigator:

Amanda Griffin

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2025-11-26.