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| Name | Class |
|---|---|
| Boston Children's Hospital | OTHER |
| University of Washington | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Performance Assessed with Experimental Sound Processing Strategy | Experimental | Patients listening to experimental cochlear implant processing strategy. |
|
| Control | No Intervention | Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation). | |
| Experimental Control | Sham Comparator | Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Speech Processing Strategy | Other | Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Slopes of the spread of excitation of the electrically evoked compound action potential responses | 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. | Baseline |
| Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves. | 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. | Baseline |
| Changes in vowel identification scores | Medial vowel identification performance in background noise. Participants will complete age-appropriate testing. | Baseline and weekly for 10 weeks after the intervention |
| Changes in sentence recognition scores | Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing. | Baseline and weekly for 10 weeks after the intervention |
| Changes in speech-gap detection thresholds | Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing. | Baseline and weekly for 10 weeks after the intervention |
| Changes in phoneme discrimination scores | Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing. |
| Measure | Description | Time Frame |
|---|---|---|
| Age | A secondary age analysis on all outcome measures will be applied. | Age at baseline |
| Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores | The IT-MAIS is a study-team-guided parental report about how infants and toddlers are responding to sound. |
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Inclusion Criteria:
Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria
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
Exclusion Criteria:
Exclusion for all Cochlear Implant Subjects:
Exclusion for all Normal Hearing Subjects:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Arenberg | Contact | 617-807-7904 | julie_arenberg@meei.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Julie Arenberg | Massachusetts Eye and Ear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mass Eye and Ear | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D003638 | Deafness |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Baseline and weekly for 10 weeks after the intervention |
| Changes in time (weeks) with programming strategy | Outcome measures will be obtained at weekly intervals during the intervention, and the weekly collection of those measures will be analyzed. | Baseline and weekly for 10 weeks after the intervention |
| Baseline, and weekly for 10 weeks after the intervention |
| Macarthur-Bates vocabulary inventory scores | This test allows the study team and parents to monitor speech and language development, specifically new word learning. | Baseline, and weekly for 10 weeks after the intervention |
| Hearing quality of life (HEARQL) scores | The HEAR-QL is a self-assessment test normed for children to assess how they hear in everyday life with different interventions | Baseline, 5 weeks, and 10 weeks after the intervention |
| Sound quality questionnaire | 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) | Baseline and weekly for 10 weeks after the intervention |
| Boston Children's Hospital | Recruiting | Waltham | Massachusetts | 02453 | United States |
|
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |