An interventional study of Experimental Speech Processing Strategy in Deafness, sponsored by Massachusetts Eye and Ear Infirmary. Recruiting at 2 sites in United States. Open to participants aged 3 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Massachusetts Eye and Ear Infirmary · Not applicable, Interventional, and Other
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.
160 studies on the registry are indexed under Deafness; 46 are open to participants now.
This study's planned enrollment of 200 is above the median of 43 across 106 interventional studies indexed under Deafness.
Browse Deafness studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria
CHILDREN Inclusion Criteria
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients listening to experimental cochlear implant processing strategy.
Other: Experimental Speech Processing Strategy
Patients listening to their clinical cochlear implant using their "own" processor (their everyday listening situation).
Patients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program.
Other: Experimental Speech Processing Strategy
Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.
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.
Time frame: 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.
Time frame: Baseline
Changes in vowel identification scores
Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and weekly for 10 weeks after the intervention
Age
A secondary age analysis on all outcome measures will be applied.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: Baseline and weekly for 10 weeks after the intervention
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