Deafness, PerceptionANI-NIHNCT07789665
Auditory Intranerve Stimulation Perceptual Study
A study testing Auditory Nerve Implant (ANI) in people with Deafness, Perception, run by Hannover Medical School at 2 sites in Germany.
Trial summary
The objective of this scientific study is to evaluate the feasibility of direct auditory nerve stimulation to elicit key percepts, specifically loudness and frequency/pitch percepts in three deaf patients participants with the new auditory nerve implant (ANI). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Deafness, Perception
- What is being tested?
- Auditory Nerve Implant (ANI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesGermany
- Study dates
- Aug 2026to 29 Feb 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤85 years
- Written informed consent
- Bilateral deafness with cochlea that does not allow the implantation of a cochlear implant (CI). This can include ossification, malformation of cochlea; poor CI performers (lowest quartile of CI performance); and patientparticipants with facial nerve stimulation using a CI which is not manageable without reduction of performance
- Eligible for routine auditory brainstem implant (ABI) where patientparticipants would undergo more invasive brainstem surgery than the ANI surgery
- Functional auditory nerve and central auditory pathway
- Post-linguistic onset of ipsilateral severe-to-profound hearing loss
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- The contralateral ear has sufficient vestibular function
- Women not able to become pregnant*
- Women not able to become pregnant defined as follows:
- at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
- hysterectomy or uterine agenesis or
- ≥ 50 years and in postmenopausal state > 1 year or
- < 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening
Who cannot join
- Medical, neurological, or psychological conditions that would contraindicate undergoing surgery, e.g. depression, acute cardiac infarction, history of stroke, dementia, epilepsy
- Additional handicaps that would prevent participation in evaluations
- Women able to become pregnant
- Pregnant women
- Persons who are deprived of their liberty on the basis of an official order or a court order or authorization
- Known allergies to one of the components of the implant (medical grade silicone, Parylene-C, Iridium oxide, Platinum-Iridium alloy (PtIr 10) and (PtIr 20) )
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- Other active devices with potential interference with the auditory nerve implant
- Presence of anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull
- Additionally, in the event of other health issues, the investigators will decide on a case-by-case basis whether to enroll the patientparticipant 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.
Germany2 sites, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, 30625
Karl-Heinz Dyballa, +4917615328589, dybala.karl-heinz@mh-hannover.de
Rolf Salcher, Dr.
- Active, not recruiting
Service provider for the performance of surgical procedures: International Neuroscience Institute
Hanover, 30625
About this study
Official title: Scientific Assessment of Auditory Intranerve Stimulation Loudness and Pitch Percepts
The objective of this scientific study is to evaluate the feasibility of direct auditory nerve stimulation to elicit key percepts, specifically loudness and frequency/pitch percepts in three deaf patients participants with the new auditory nerve implant (ANI). During the year with temporary stimulation of the auditory nerve, patients participants are expected to participate for 14 months, consisting of: two months for surgery for the nerve implant and healing phase, one month initial follow-up, ten months of follow-up care and study testing, and one month for explanation and post-operative observation.
Read the detailed description
The auditory nerve implant (ANI) targets the auditory nerve directly between the cochlea and the brainstem, whereas current implants like the cochlear and brainstem implants stimulate the cochlea or brainstem, respectively. By providing direct stimulation within the auditory nerve, a nerve implant offers a better electrode-nerve interface and may achieve improved hearing compared to a cochlear or brainstem implant. Preliminary results in animals, computer simulations, and acute clinical studies showed significantly better performance compared to other hearing aidsoptions. This study aims to investigate the extent to which these benefits are perceptible in the human auditory nerve.
The primary goal of this study is to gain scientific insight into the hearing experience with the direct auditory nerve stimulation. However, the results could contribute to the development of new hearing implants that directly stimulate the auditory nerve.
- Conditions
- Deafness, Perception
- Being tested
- Auditory Nerve Implant (ANI)
- 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.
Auditory Nerve Implant (ANI)Device
The investigational research device consists of a speech processor worn on the ear and an implant body with an electrode array.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Direct Auditory Nerve Stimulation | Experimental | Patients Participants will be implanted with an Auditory Nerve Implant (ANI) for one year to evaluate key perceptual measures of temporary direct auditory nerve stimulation. Safety and efficacy will also be evaluated, as well as different speech perception capabilities. Receives: Device: Auditory Nerve Implant (ANI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pitch perception performance of ANI
Systematic place pitch ordering maintained on month 12
Measured: 12 months
Secondary outcomes (1)
Loudness perception performance of ANI
Collection of loudness growth functions (LGFs) across single electrodes that have a dynamic range greater than 6 dB and maintained on month 12
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study startAug 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deafness, PerceptionStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Lenarz, Prof., Principal investigator, Hannover Medical SchoolAmir Samii, Prof., Principal investigator, International Neuroscience Institute Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789665
- Sponsor's protocol ID
- 0000509678
- Other IDs
- No.11979-BO-MPDG-M-2025
- Acronym
- ANI-NIH
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Assessment of Auditory Intranerve Stimulation Loudness and Pitch Percepts
- ClinicalTrials.gov ID
- NCT07789665
- Acronym / sponsor ID
- ANI-NIH / 0000509678
- Conditions
- Deafness, Perception
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 27 Aug 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.
The objective of this scientific study is to evaluate the feasibility of direct auditory nerve stimulation to elicit key percepts, specifically loudness and frequency/pitch percepts in three deaf patients participants with the new auditory nerve implant (ANI). During the year with temporary stimulation of the auditory nerve, patients participants are expected to participate for 14 months, consisting of: two months for surgery for the nerve implant and healing phase, one month initial follow-up, ten months of follow-up care and study testing, and one month for explanation and post-operative observation.
Detailed description
The auditory nerve implant (ANI) targets the auditory nerve directly between the cochlea and the brainstem, whereas current implants like the cochlear and brainstem implants stimulate the cochlea or brainstem, respectively. By providing direct stimulation within the auditory nerve, a nerve implant offers a better electrode-nerve interface and may achieve improved hearing compared to a cochlear or brainstem implant. Preliminary results in animals, computer simulations, and acute clinical studies showed significantly better performance compared to other hearing aidsoptions. This study aims to investigate the extent to which these benefits are perceptible in the human auditory nerve.
The primary goal of this study is to gain scientific insight into the hearing experience with the direct auditory nerve stimulation. However, the results could contribute to the development of new hearing implants that directly stimulate the auditory nerve.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Direct Auditory Nerve Stimulation | Experimental | Device: Auditory Nerve Implant (ANI)Patients Participants will be implanted with an Auditory Nerve Implant (ANI) for one year to evaluate key perceptual measures of temporary direct auditory nerve stimulation. Safety and efficacy will also be evaluated, as well as different speech perception capabilities. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 and ≤85 years
- Written informed consent
- Bilateral deafness with cochlea that does not allow the implantation of a cochlear implant (CI). This can include ossification, malformation of cochlea; poor CI performers (lowest quartile of CI performance); and patientparticipants with facial nerve stimulation using a CI which is not manageable without reduction of performance
- Eligible for routine auditory brainstem implant (ABI) where patientparticipants would undergo more invasive brainstem surgery than the ANI surgery
- Functional auditory nerve and central auditory pathway
Key exclusion criteria (9 listed)
- Medical, neurological, or psychological conditions that would contraindicate undergoing surgery, e.g. depression, acute cardiac infarction, history of stroke, dementia, epilepsy
- Additional handicaps that would prevent participation in evaluations
- Women able to become pregnant
- Pregnant women
- Persons who are deprived of their liberty on the basis of an official order or a court order or authorization
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 |
|---|---|---|
| Auditory Nerve Implant (ANI)The investigational research device consists of a speech processor worn on the ear and an implant body with an electrode array. | Device | Experimental: Direct Auditory Nerve Stimulation |
Primary outcome
Pitch perception performance of ANI
Time frame: 12 months
Systematic place pitch ordering maintained on month 12
1 secondary outcome
Loudness perception performance of ANI
Time frame: 12 months
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 27 Aug 2026.
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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.
Thomas Lenarz, Prof. principal investigator
Hannover Medical School
Amir Samii, Prof. principal investigator
International Neuroscience Institute Hannover
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Nerve Implant (ANI) in people with Deafness, Perception, run by Hannover Medical School at 2 sites in Germany.
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 13 inclusion and 9 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 27 Aug 2026. 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 Germany. 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 Hubert Lim, Prof. (+16126264565, Hlim@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pitch perception performance of ANI (time frame: 12 months). 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 27 Aug 2026.