DeafnessNCT07683689
Improving Cochlear Implant Outcomes Through Modeling and Programming Strategies Based on Human Inner Ear Pathology
A study testing ENI-Based Experimental Program 1 and ENI-Based Experimental Program 2 in people with Deafness, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
Cochlear implants are devices placed in the inner ear through surgery to help people with severe to profound hearing loss. While these devices work well overall, results vary widely from person to person. Many people with cochlear implants still have trouble understanding speech in noisy places and enjoying music. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Deafness
- What is being tested?
- ENI-Based Experimental Program 1 and ENI-Based Experimental Program 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Jul 2028
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80 years old
- Native speakers of American English or Multilingual
- Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer)
- At least 6 months of listening experience with their cochlear implant, but could be recruited and consented prior.
- Bilateral hearing loss
Who cannot join
- Inability to provide informed consent
- Lost their hearing prior to the age of language acquisition (3-4 years) but did not receive a cochlear implant until adulthood
- Do not have age-appropriate speech perception testing from clinical visits or do not use their implant for oral communication
- Have neurological disease
- Have unmanageable facial nerve stimulation or pain as a result of their implant
- Does not tolerate implant well
- Unable to carry out the study protocol or tasks required in the study
- Poor vision such that the subject cannot adequately perform the study tasks on the computer screen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts Eye and Ear
Boston, Massachusetts, 02171
Julie Arenberg, PhD, CCC-A, 617-807-7904, julie_arenberg@meei.harvard.edu
About this study
Cochlear implants are devices placed in the inner ear through surgery to help people with severe to profound hearing loss. While these devices work well overall, results vary widely from person to person. Many people with cochlear implants still have trouble understanding speech in noisy places and enjoying music.
This study looks at whether customizing the way a cochlear implant is programmed, based on the health of the hearing nerve in different areas of the ear, can help people understand speech better in noisy settings. The researchers will adjust or turn off certain electrodes in areas where the nerve appears weaker, then test whether this improves hearing compared to each person's everyday program. They will also examine whether giving people time to get used to the new program leads to better results.
Read the detailed description
Cochlear implants are surgically placed in the inner ears of people with severe to profound hearing loss. Although these devices are generally successful, outcomes differ a great deal from one person to the next. Many people who use cochlear implants continue to struggle with understanding speech when there is background noise and with appreciating music. More research is needed to understand why results vary so much among cochlear implant users.
The main goal of this study is to better understand the underlying condition of the inner ear and how it relates to how well people hear with their cochlear implant. The researchers will use this knowledge to test new ways of programming the devices. A cochlear implant has multiple electrodes, and each one stimulates a different region of the hearing nerve. In some people, certain regions of the nerve are healthier than others. By estimating where the nerve is weaker or stronger, the researchers hope to program the device in a way that takes advantage of the healthier areas.
The study has one main aim with two parts:
The first part compares how well participants understand speech in noise using their usual everyday program versus an experimental program. In the experimental program, the electrical signal is narrowed and focused for electrodes that are farther from healthy nerve regions, and electrodes near poorly functioning nerve regions may be turned off. These adjustments are guided by a model of nerve health developed in earlier research.
The second part looks at whether performance improves after participants spend four weeks getting used to the experimental program. The researchers expect that programming based on each person's individual nerve health will improve their ability to understand speech in noise, and that this improvement will be greater after they have had time to adjust to the new program.
This work is expected to provide a better understanding of how long a person needs to adapt when their programming strategy changes. The findings could be applied fairly quickly in clinical settings to improve speech understanding for both adults and children who use cochlear implants.
- Conditions
- Deafness
- Being tested
- Everyday Clinical Listening Program (Control), ENI-Based Experimental Program 1, ENI-Based Experimental Program 2
- Keywords
- cochlear implant
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everyday Clinical Listening Program (Control)Device
The participant's standard clinical cochlear implant sound-processing program, as currently fit for everyday use. This serves as the within-subjects control condition and remains available as a backup throughout the take-home trial.
ENI-Based Experimental Program 1Device
An experimental cochlear implant sound-processing strategy that applies focused electrical fields for electrodes distant from regions of healthy neural tissue and/or deactivates channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model. Tested acutely in the lab and during one 4-week take-home interval.
ENI-Based Experimental Program 2Device
A second experimental cochlear implant sound-processing strategy applying focused electrical fields and/or channel deactivation based on electrode-neuron interface estimates, configured differently from Experimental Program 1. Tested acutely in the lab and during one 4-week take-home interval.
| Study group | Role | What they receive |
|---|---|---|
| All Participants (Within-Subjects Crossover) | Experimental | This is a within-subjects study in which all enrolled participants receive every condition. Each participant's everyday clinical listening program serves as the control and is compared against two experimental sound-processing strategies based on electrode-neuron interface (ENI) estimates.
In the in-lab phase (Sub-Aim 1.1), all programs are compared acutely. In the take-home phase (Sub-Aim 1.2), participants complete a 12-week crossover consisting of 4 weeks with their clinical program followed by 4 weeks with each experimental strategy, with the order of programs randomized. Receives: Device: Everyday Clinical Listening Program (Control); Device: ENI-Based Experimental Program 1; Device: ENI-Based Experimental Program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sentence Recognition in Noise (Everyday Program vs. Experimental Programs), In-Lab
Sentence recognition in background noise will be measured using the American Matrix Test (AMT), an adaptive, closed-set speech-in-noise test consisting of 4 blocks of 20 sentences each (5 words per sentence). The adaptive procedure yields a speech reception threshold expressed in dB SNR, the signal-to-noise ratio at which the participant correctly identifies 50 percent of words, with lower (more negative) values indicating better performance. Scores obtained with the participant's everyday clinical listening program (control) will be compared to scores obtained with two experimental sound-processing strategies that apply focused electrical fields for distant electrodes and/or deactivate channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model.
Measured: Across a minimum of two in-lab sessions (each up to 3.5 hours)
Change in Vowel Identification (Everyday Program vs. Experimental Programs), In-Lab
Medial vowel identification will be measured using a closed-set vowel discrimination task in quiet and at a +10 dB signal-to-noise ratio in four-talker babble noise. Performance is scored as percent correct, with higher values indicating better performance. Scores obtained with the participant's everyday clinical program (control) will be compared to scores obtained with the two experimental sound-processing strategies.
Measured: Across a minimum of two in-lab sessions (each up to 3.5 hours)
Secondary outcomes (2)
Change in Sentence Recognition in Noise After 4 Weeks of Acclimatization (Crossover)
Using a randomized crossover design, sentence recognition in noise (American Matrix Test) will be assessed before and after 4 weeks of at-home listening for the control program and each experimental program. The adaptive procedure yields a speech reception threshold in dB SNR, with lower (more negative) values indicating better performance. Participants complete 4 weeks of baseline testing with their clinical program followed by 4 weeks with each of the two experimental strategies. The outcome is the change in score across time points and programs, evaluating the effect of acclimatization.
Measured: Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial
Change in Vowel Identification After 4 Weeks of Acclimatization (Crossover)
Using the randomized crossover design, medial vowel identification will be assessed before and after 4 weeks of at-home listening for the control and experimental programs. Performance is scored as percent correct, with higher values indicating better performance. The outcome evaluates the effect of acclimatization on performance.
Measured: Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Oct 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie G. Arenberg, CCC-A, Massachusetts Eye and Ear Infirmary
- Investigators
- Julie Arenberg, PhD, CCC-A, Principal investigator, Massachusetts Eye and Ear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683689
- Sponsor's protocol ID
- 2026P001659
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cochlear Implant Outcomes Through Modeling and Programming Strategies Based on Human Inner Ear Pathology
- ClinicalTrials.gov ID
- NCT07683689
- Acronym / sponsor ID
- 2026P001659
- Conditions
- Deafness
- Keywords
- cochlear implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 6 Jul 2026 (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.
Cochlear implants are devices placed in the inner ear through surgery to help people with severe to profound hearing loss. While these devices work well overall, results vary widely from person to person. Many people with cochlear implants still have trouble understanding speech in noisy places and enjoying music.
This study looks at whether customizing the way a cochlear implant is programmed, based on the health of the hearing nerve in different areas of the ear, can help people understand speech better in noisy settings. The researchers will adjust or turn off certain electrodes in areas where the nerve appears weaker, then test whether this improves hearing compared to each person's everyday program. They will also examine whether giving people time to get used to the new program leads to better results.
Detailed description
Cochlear implants are surgically placed in the inner ears of people with severe to profound hearing loss. Although these devices are generally successful, outcomes differ a great deal from one person to the next. Many people who use cochlear implants continue to struggle with understanding speech when there is background noise and with appreciating music. More research is needed to understand why results vary so much among cochlear implant users.
The main goal of this study is to better understand the underlying condition of the inner ear and how it relates to how well people hear with their cochlear implant. The researchers will use this knowledge to test new ways of programming the devices. A cochlear implant has multiple electrodes, and each one stimulates a different region of the hearing nerve. In some people, certain regions of the nerve are healthier than others. By estimating where the nerve is weaker or stronger, the researchers hope to program the device in a way that takes advantage of the healthier areas.
The study has one main aim with two parts:
The first part compares how well participants understand speech in noise using their usual everyday program versus an experimental program. In the experimental program, the electrical signal is narrowed and focused for electrodes that are farther from healthy nerve regions, and electrodes near poorly functioning nerve regions may be turned off. These adjustments are guided by a model of nerve health developed in earlier research.
The second part looks at whether performance improves after participants spend four weeks getting used to the experimental program. The researchers expect that programming based on each person's individual nerve health will improve their ability to understand speech in noise, and that this improvement will be greater after they have had time to adjust to the new program.
This work is expected to provide a better understanding of how long a person needs to adapt when their programming strategy changes. The findings could be applied fairly quickly in clinical settings to improve speech understanding for both adults and children who use cochlear implants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants (Within-Subjects Crossover) | Experimental | Device: Everyday Clinical Listening Program (Control), Device: ENI-Based Experimental Program 1, Device: ENI-Based Experimental Program 2This is a within-subjects study in which all enrolled participants receive every condition. Each participant's everyday clinical listening program serves as the control and is compared against two experimental sound-processing strategies based on electrode-neuron interface (ENI) estimates. In the in-lab phase (Sub-Aim 1.1), all programs are compared acutely. In the take-home phase (Sub-Aim 1.2), participants complete a 12-week crossover consisting of 4 weeks with their clinical program followed by 4 weeks with each experimental strategy, with the order of programs randomized. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 80 years old
- Native speakers of American English or Multilingual
- Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer)
- At least 6 months of listening experience with their cochlear implant, but could be recruited and consented prior.
- Bilateral hearing loss
Key exclusion criteria (8 listed)
- Inability to provide informed consent
- Lost their hearing prior to the age of language acquisition (3-4 years) but did not receive a cochlear implant until adulthood
- Do not have age-appropriate speech perception testing from clinical visits or do not use their implant for oral communication
- Have neurological disease
- Have unmanageable facial nerve stimulation or pain as a result of their implant
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 |
|---|---|---|
| Everyday Clinical Listening Program (Control)The participant's standard clinical cochlear implant sound-processing program, as currently fit for everyday use. This serves as the within-subjects control condition and remains available as a backup throughout the take-home trial. | Device | All Participants (Within-Subjects Crossover) |
| ENI-Based Experimental Program 1An experimental cochlear implant sound-processing strategy that applies focused electrical fields for electrodes distant from regions of healthy neural tissue and/or deactivates channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model. Tested acutely in the lab and during one 4-week take-home interval. | Device | All Participants (Within-Subjects Crossover) |
| ENI-Based Experimental Program 2A second experimental cochlear implant sound-processing strategy applying focused electrical fields and/or channel deactivation based on electrode-neuron interface estimates, configured differently from Experimental Program 1. Tested acutely in the lab and during one 4-week take-home interval. | Device | All Participants (Within-Subjects Crossover) |
Primary outcome
Change in Sentence Recognition in Noise (Everyday Program vs. Experimental Programs), In-Lab
Time frame: Across a minimum of two in-lab sessions (each up to 3.5 hours)
Sentence recognition in background noise will be measured using the American Matrix Test (AMT), an adaptive, closed-set speech-in-noise test consisting of 4 blocks of 20 sentences each (5 words per sentence). The adaptive procedure yields a speech reception threshold expressed in dB SNR, the signal-to-noise ratio at which the participant correctly identifies 50 percent of words, with lower (more negative) values indicating better performance. Scores obtained with the participant's everyday clinical listening program (control) will be compared to scores obtained with two experimental sound-processing strategies that apply focused electrical fields for distant electrodes and/or deactivate channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model.
Change in Vowel Identification (Everyday Program vs. Experimental Programs), In-Lab
Time frame: Across a minimum of two in-lab sessions (each up to 3.5 hours)
Medial vowel identification will be measured using a closed-set vowel discrimination task in quiet and at a +10 dB signal-to-noise ratio in four-talker babble noise. Performance is scored as percent correct, with higher values indicating better performance. Scores obtained with the participant's everyday clinical program (control) will be compared to scores obtained with the two experimental sound-processing strategies.
2 secondary outcomes
Change in Sentence Recognition in Noise After 4 Weeks of Acclimatization (Crossover)
Time frame: Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial
Change in Vowel Identification After 4 Weeks of Acclimatization (Crossover)
Time frame: Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial
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 9 Oct 2026.
- Individual participant dataSharing planned: No
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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, PhD, CCC-A principal investigator
Massachusetts Eye and Ear
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENI-Based Experimental Program 1 and ENI-Based Experimental Program 2 in people with Deafness, run by Massachusetts Eye and Ear Infirmary at 1 site 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 5 inclusion and 8 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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, PhD, CCC-A (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?
Change in Sentence Recognition in Noise (Everyday Program vs. Experimental Programs), In-Lab (time frame: Across a minimum of two in-lab sessions (each up to 3.5 hours)). The study lists 2 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 9 Oct 2026.