Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Healthy Volunteers: t
View:

‣ 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.

Locations
United States
Massachusetts
Mass Eye and Ear
RECRUITING
Boston
Boston Children's Hospital
RECRUITING
Waltham
Contact Information
Primary
Julie Arenberg
julie_arenberg@meei.harvard.edu
617-807-7904
Time Frame
Start Date: 2022-09-16
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 200
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, Boston Children's Hospital
Leads: Massachusetts Eye and Ear Infirmary

This content was sourced from clinicaltrials.gov