DeafnessNCT05867173
Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces
A study testing Experimental Speech Processing Strategy in people with Deafness, run by Massachusetts Eye and Ear Infirmary at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Deafness
- What is being tested?
- Experimental Speech Processing Strategy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Sep 2022to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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 join
- 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
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mass Eye and Ear
Boston, Massachusetts, 02114
Julie Arenberg, 617-807-7904, julie_arenberg@meei.harvard.edu
Julie Arenberg
- Recruiting
Boston Children's Hospital
Waltham, Massachusetts, 02453
Amanda Griffin, 781-216-3657, amanda.griffin@childrens.harvard.edu
Amanda Griffin
About this study
Official title: Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners
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.
- Conditions
- Deafness
- Being tested
- Experimental Speech Processing Strategy
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Speech Processing StrategyOther
Patient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy.
| Study group | Role | What they receive |
|---|---|---|
| Performance Assessed with Experimental Sound Processing Strategy | Experimental | Patients listening to experimental cochlear implant processing strategy. Receives: Other: Experimental Speech 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. Receives: Other: Experimental Speech Processing Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Changes in vowel identification scores
Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and weekly for 10 weeks after the intervention
Secondary outcomes (5)
Age
A secondary age analysis on all outcome measures will be applied.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: Baseline and weekly for 10 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start16 Sep 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, University of Washington
- Responsible party
- Principal investigator, Julie G. Arenberg, CCC-A, Massachusetts Eye and Ear Infirmary
- Investigators
- Julie Arenberg, Principal investigator, Massachusetts Eye and Ear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867173
- Sponsor's protocol ID
- MGB_2019P000239
- Status last verified
- Nov 2025
- First submitted
- 27 Feb 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners
- ClinicalTrials.gov ID
- NCT05867173
- Acronym / sponsor ID
- MGB_2019P000239
- Conditions
- Deafness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, University of Washington
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Performance Assessed with Experimental Sound Processing Strategy | Experimental | Other: Experimental Speech Processing StrategyPatients 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 | Other: Experimental Speech Processing StrategyPatients listening to experimental cochlear implant using a processing strategy like thier clinical program, a "clinical like" program. |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Inability to provide informed consent
- Hearing loss, or significant history of hearing related issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Speech Processing StrategyPatient's will listen with an experimental speech processor, programmed with a dynamic focusing strategy. | Other | Experimental Control, Performance Assessed with Experimental Sound Processing Strategy |
Primary outcome
Slopes of the spread of excitation of the electrically evoked compound action potential responses
Time frame: 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.
Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and weekly for 10 weeks after the intervention
Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing.
Changes in time (weeks) with programming strategy
Time frame: 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.
5 secondary outcomes
Age
Time frame: Age at baseline
Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores
Time frame: Baseline, and weekly for 10 weeks after the intervention
Macarthur-Bates vocabulary inventory scores
Time frame: Baseline, and weekly for 10 weeks after the intervention
Hearing quality of life (HEARQL) scores
Time frame: Baseline, 5 weeks, and 10 weeks after the intervention
Sound quality questionnaire
Time frame: Baseline and weekly for 10 weeks after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Arenberg principal investigator
Massachusetts Eye and Ear
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Speech Processing Strategy in people with Deafness, run by Massachusetts Eye and Ear Infirmary at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Arenberg (617-807-7904, julie_arenberg@meei.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slopes of the spread of excitation of the electrically evoked compound action potential responses (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.