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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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