Sensori-Neural DeafnessNCT06699797
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
A study testing Acclaim Cochlear Implant in people with Sensori-Neural Deafness and Sensorineural Hearing Loss, run by Envoy Medical Corporation at 7 sites in United States.
Trial summary
The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sensori-Neural Deafness, Sensorineural Hearing Loss, Sensorineural Hearing Loss (Disorder)
- What is being tested?
- Acclaim Cochlear Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Feb 2025to Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form.
- Able to understand and comply with the requirements of the Study, including surgery and post-implant rehabilitation.
- Ability to read, write, comprehend, and speak fluently in English.
- Post-lingually deafened.
- 18 years of age or older at the time of informed consent.
- Good health and absence of significant comorbidities, in the opinion of the Principal Investigator.
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- At least 30 days of experience with appropriate bilaterally fit hearing aids.
- Ear to be implanted has severe to profound hearing loss defined as pure tone average at 500, 1000, 2000 and 4000 Hz ≥ 70 dB.
- Contralateral ear has moderately severe to profound hearing loss defined as pure tone average at 500, 1000, 2000 and 4000 Hz ≥ 60 dB.
- Limited benefit from amplification defined as CNC monosyllabic word recognition ≤ 40% in the ear to be implanted and ≤ 60% in the contralateral ear, in the aided condition.
- Normal middle ear function based on otoscopy and tympanometry.
- An accessible cochlear lumen and intact cochlear nerve, and no known lesions on the auditory nerve or auditory central nervous system, on the ear to be implanted confirmed with MRI or CT scan.
Who cannot join
- Documented duration of severe to profound hearing loss for 20 or more years.
- Previous cochlear implantation in either ear.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Active external or middle ear pathology (i.e., infections, tympanic membrane perforation, or ossicular chain issues) in the ear to be implanted at the time of screening or in the past 6 months, that could impact the proper functioning of the device.
- Known history of chronic eustachian tube dysfunction.
- Prior surgery in the middle ear, inner ear, neck, or infraclavicular region which is anticipated to prevent proper placement or function of the Acclaim CI.
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- Hearing loss/disorder of retrocochlear origin.
- Diagnosis of auditory neuropathy.
- Currently using other active implants that are expected to interfere with the Acclaim CI position or function.
- Known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium, platinum, or gold.
- Known hypersensitivity or contraindications to procedural or post-procedural medications that cannot be adequately managed medically.
- Pregnancy at the time of Acclaim CI implantation.
- Known need for MRI or ionizing radiation treatment during Study participation.
- Unrealistic expectations on the Participant's part regarding the possible benefits, risks, and limitations inherent to the surgical procedure and use of the Acclaim CI, in the Principal Investigator's opinion.
- Unwillingness or inability to comply with all investigational requirements.
- Additional conditions that would prevent completion of all Study requirements, in the opinion of the Principal Investigator.
- Participation in an investigational drug study or another device study within 3 months of the Screening Visit.
- Previous history of meningitis.
- Deafness, in the ear to be implanted, due to:
- a damaged or absent tympanic membrane,
- a damaged or absent middle ear,
- an absent cochlea,
- lesions on the acoustic nerve, or
- lesions on the central auditory pathway
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
MUSC Health
Charleston, South Carolina, 29425
Cleveland Clinic
Cleveland, Ohio, 44195
University of Florida Health
Gainesville, Florida, 32607
Hearts for Hearing
Oklahoma City, Oklahoma, 73114
Mayo Clinic
Rochester, Minnesota, 55902
Shohet Ear Associates
Seal Beach, California, 90740
Center for Neurosciences Ear and Hearing Center
Tucson, Arizona, 85718
About this study
The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant. The main questions it aims to answer are:
- Does the Acclaim CI device help participants hear words better compared to before the implants?
- What medical problems do participants have after the Acclaim CI device was implanted?
Participants will:
- Have the Acclaim CI implanted; and
- Visit the clinical site for checkups and tests at 1-Month, 3-Months, 6-Months, and at 1-year and 2-years after the device has been turned on.
- Conditions
- Sensori-Neural Deafness, Sensorineural Hearing Loss, Sensorineural Hearing Loss (Disorder), Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Profound, Sensorineural Hearing Loss, Severe
- Being tested
- Acclaim Cochlear Implant
- Keywords
- cochlear implant, fully implanted hearing device
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acclaim Cochlear ImplantDevice
Participants with the Acclaim CI device will be tested during follow-up with their hearing results compared to baseline (before the device implant procedure).
| Study group | Role | What they receive |
|---|---|---|
| Acclaim CI | Experimental | Participants who receive the Acclaim CI, or who have the implant procedure attempted. Receives: Device: Acclaim Cochlear Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
In the Safety Set, frequency and severity of device and procedure related adverse events, including device deficiencies, reported through 12-Month post-activation
Measured: From consent to the 1-year follow-up visit
In the Full Analysis Set, within-subject difference between CNC word score obtained at 12-months post-activation in the Acclaim Only condition and the pre-operative aided score in the ear to be implanted
Measured: From consent to the 1-year follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start6 Feb 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sensori-Neural 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Envoy Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699797
- Sponsor's protocol ID
- A200
- Status last verified
- Oct 2025
- First submitted
- 19 Nov 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
- ClinicalTrials.gov ID
- NCT06699797
- Acronym / sponsor ID
- A200
- Conditions
- Sensori-Neural Deafness, Sensorineural Hearing Loss, Sensorineural Hearing Loss (Disorder), Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Profound, Sensorineural Hearing Loss, Severe
- Keywords
- cochlear implant, fully implanted hearing device
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Envoy Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 21 Nov 2024 (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.
The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant. The main questions it aims to answer are:
- Does the Acclaim CI device help participants hear words better compared to before the implants?
- What medical problems do participants have after the Acclaim CI device was implanted?
Participants will:
- Have the Acclaim CI implanted; and
- Visit the clinical site for checkups and tests at 1-Month, 3-Months, 6-Months, and at 1-year and 2-years after the device has been turned on.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acclaim CI | Experimental | Device: Acclaim Cochlear ImplantParticipants who receive the Acclaim CI, or who have the implant procedure attempted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed and dated informed consent form.
- Able to understand and comply with the requirements of the Study, including surgery and post-implant rehabilitation.
- Ability to read, write, comprehend, and speak fluently in English.
- Post-lingually deafened.
- 18 years of age or older at the time of informed consent.
Key exclusion criteria (24 listed)
- Documented duration of severe to profound hearing loss for 20 or more years.
- Previous cochlear implantation in either ear.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Active external or middle ear pathology (i.e., infections, tympanic membrane perforation, or ossicular chain issues) in the ear to be implanted at the time of screening or in the past 6 months, that could impact the proper functioning of the device.
- Known history of chronic eustachian tube dysfunction.
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 |
|---|---|---|
| Acclaim Cochlear ImplantParticipants with the Acclaim CI device will be tested during follow-up with their hearing results compared to baseline (before the device implant procedure). | Device | Acclaim CI |
Primary outcome
In the Safety Set, frequency and severity of device and procedure related adverse events, including device deficiencies, reported through 12-Month post-activation
Time frame: From consent to the 1-year follow-up visit
In the Full Analysis Set, within-subject difference between CNC word score obtained at 12-months post-activation in the Acclaim Only condition and the pre-operative aided score in the ear to be implanted
Time frame: From consent to the 1-year follow-up visit
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 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acclaim Cochlear Implant in people with Sensori-Neural Deafness and Sensorineural Hearing Loss, run by Envoy Medical Corporation at 7 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 12 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In the Safety Set, frequency and severity of device and procedure related adverse events, including device deficiencies, reported through 12-Month post-activation (time frame: From consent to the 1-year follow-up visit). 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 16 Mar 2026.