NCT05867173 · Massachusetts Eye and Ear Infirmary
Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
What this study is 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.
View original scientific description
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.
Interventions
OTHER
Experimental Speech Processing Strategy
Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.
Primary outcome measures
Slopes of the spread of excitation of the electrically evoked compound action potential responses
Time frame: Baseline
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.
Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.
Time frame: Baseline
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.
Changes in vowel identification scores
Time frame: Baseline and weekly for 10 weeks after the intervention
Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.
Changes in sentence recognition scores
Time frame: Baseline and weekly for 10 weeks after the intervention
Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing.
Changes in speech-gap detection thresholds
Time frame: Baseline and weekly for 10 weeks after the intervention
Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing.
Changes in phoneme discrimination scores
Time frame: Baseline and weekly for 10 weeks after the intervention
Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing.
Changes in time (weeks) with programming strategy
Time frame: Baseline and weekly for 10 weeks after the intervention
Outcome measures will be obtained at weekly intervals during the intervention, and the weekly collection of those measures will be analyzed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Boston, Massachusetts
- Waltham, Massachusetts
Collaborators
Boston Children's Hospital, University of Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 26, 2025 · Source of record for eligibility and locations