Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
Key facts
- Who runs it
- Massachusetts Eye and Ear Infirmary
- Where
- Boston and Waltham, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 16 Sept 2022
- Expected to end
- 31 Mar 2027
- Type of study
- Interventional, 3 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Experimental Speech Processing Strategy
- Record updated
- 26 November 2025
Who can take part
- Age
- 3 months and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Exclusion for all Cochlear Implant Subjects:
- Hearing loss, or significant history of hearing related issues
- 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
- Inability to provide informed consent
- Unable to carry out the study protocol or tasks required in the study; Exclusion for all Normal Hearing Subjects:
- Inability to provide informed consent
- Unable to carry out the study protocol or tasks required in the study
Where in United States
- Mass Eye and EarBoston, United StatesContact: Julie ArenbergTaking people
- Boston Children's HospitalWaltham, United StatesContact: Amanda GriffinTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Performance Assessed with Experimental Sound Processing StrategyTreatment being tested
Patients listening to experimental cochlear implant processing strategy.
Treatment: Experimental Speech Processing Strategy
- ControlNo study treatment, for comparison
Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation).
- Experimental ControlSham treatment, for comparison
Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program.
Treatment: Experimental Speech Processing Strategy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners
- Record updated
- 26 November 2025