Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

Mass Eye and Ear

Status: Enrolling

Conditions: Deafness

Treatments: Other: Experimental Speech Processing Strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT05867173

MGB_2019P000239

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 6+ months old

Volunteers: Accepts Healthy Volunteers

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 6 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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200 participants in 3 patient groups

Performance Assessed with Experimental Sound Processing Strategy

Experimental group

Description:

Patients listening to experimental cochlear implant processing strategy.

Treatment:

Other: Experimental Speech Processing Strategy

Control

No Intervention group

Description:

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

Experimental Control

Sham Comparator group

Description:

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

Treatment:

Other: Experimental Speech Processing Strategy