Deafness
Conditions
Brief 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.
Interventions
OTHERExperimental Speech Processing Strategy
Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.
Sponsors
Boston Children's Hospital
University of Washington
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
Yes
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in time (weeks) with programming strategy | 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. |
| Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves. | 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 | 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 | 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 | 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 | Baseline and weekly for 10 weeks after the intervention | Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing. |
| Slopes of the spread of excitation of the electrically evoked compound action potential responses | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores | Baseline, and weekly for 10 weeks after the intervention | The IT-MAIS is a study-team-guided parental report about how infants and toddlers are responding to sound. |
| Macarthur-Bates vocabulary inventory scores | Baseline, and weekly for 10 weeks after the intervention | This test allows the study team and parents to monitor speech and language development, specifically new word learning. |
| Hearing quality of life (HEARQL) scores | Baseline, 5 weeks, and 10 weeks after the intervention | The HEAR-QL is a self-assessment test normed for children to assess how they hear in everyday life with different interventions |
| Sound quality questionnaire | Baseline and weekly for 10 weeks after the intervention | Participants will be asked to rate sound quality with different interventions in comparison to their everyday listening on a 7-point scale (from minus 3 - much worse, up to plus 3 - much better, 0 is the same) |
| Age | Age at baseline | A secondary age analysis on all outcome measures will be applied. |
Countries
United States
Contacts
Primary ContactJulie Arenberg
Outcome results
None listed