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RecruitingNCT07789665ANI-NIHUpdated Aug 27, 2026

Auditory Intranerve Stimulation Perceptual Study

An interventional study of Auditory Nerve Implant (ANI) in Deafness, Perception, sponsored by Hannover Medical School. Recruiting at 2 sites in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Hannover Medical School · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Deafness, Perception
03

In context

Hearing Loss, Sensorineural

346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.

This study's planned enrollment of 5 is below the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.

Browse Hearing Loss, Sensorineural studies →

Lead sponsor

Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.

Browse Hannover Medical School studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥18 and ≤85 years
  2. Written
  3. 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
  4. Eligible for routine auditory brainstem implant (ABI) where patientparticipants would undergo more invasive brainstem surgery than the ANI surgery
  5. Functional auditory nerve and central auditory pathway
  6. Post-linguistic onset of ipsilateral severe-to-profound hearing loss
  7. The contralateral ear has sufficient vestibular function

  8. 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 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

Exclusion criteria

Exclusion Criteria:

  1. Medical, neurological, or psychological conditions that would contraindicate undergoing surgery, e.g. depression, acute cardiac infarction, history of stroke, dementia, epilepsy
  2. Additional handicaps that would prevent participation in evaluations
  3. Women able to become pregnant
  4. Pregnant women
  5. Persons who are deprived of their liberty on the basis of an official order or a court order or authorization
  6. 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) )
  7. Other active devices with potential interference with the auditory nerve implant
  8. Presence of anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull
  9. 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
Terms in these criteria, in plain language(2)

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.

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.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Experimental: Direct Auditory Nerve Stimulation

    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.

    Device: Auditory Nerve Implant (ANI)

Interventions

  • DeviceAuditory Nerve Implant (ANI)

    The investigational research device consists of a speech processor worn on the ear and an implant body with an electrode array.

06

What researchers measure

Primary outcomes

  1. Pitch perception performance of ANI

    Systematic place pitch ordering maintained on month 12

    Time frame: 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

    Time frame: 12 months

Other outcomes

  1. Frequency Resolution

    Minimum frequency specificity (i.e., current spread) of electrodes is narrower than 0.8 mm in bandwidth maintained on month 12

    Time frame: 12 months

  2. Position of ANI electrode array in auditory nerve

    Evaluation of the final position of the ANI electrode array. The number of electrodes eliciting auditory activation will be measured. The stability of the percepts elicited will also be measured. Both of these measurements provide the stability of the electrode array implanted within the auditory nerve.

    Time frame: 12 months

  3. Collection of adverse events

    Collection of adverse events during the evaluation period

    Time frame: 12 months

07

Study locations

1 of 2 sites recruiting
  • Hannover Medical School
    Hanover, 30625, Germany
    Recruiting
    • Karl-Heinz Dyballa · Contactdybala.karl-heinz@mh-hannover.de · +4917615328589
    • Rolf Salcher, Dr. · Sub investigator
    • Max Timm, Dr · Sub investigator
    • Waldo Nogueira, Prof. · Sub investigator
    • Karl-Heinz Dyballa, Dr. · Sub investigator
    • Thomas Lenarz, Prof. · Principal investigator
  • Service provider for the performance of surgical procedures: International Neuroscience Institute
    Hanover, 30625, Germany
    Active, not recruiting

    Not enrolling at this site.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Feb 2028, 18 months later.

Of 82 non-industry interventional studies with no phase under Hearing Loss, Sensorineural, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's planned 18 months is below that.

Counting every sponsor, half of 162 studies reached it within 22 months; a quarter within 6 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 27, 2026
StartEst.
Aug 2026
Primary completionEst.
Feb 29, 2028
CompletionEst.
Feb 29, 2028
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07789665
Lead sponsor
Hannover Medical School
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Aug 2026 (estimated)
Primary completion
Feb 29, 2028 (estimated)
Completion
Feb 29, 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Hubert Lim, Prof.
Contact
Hlim@umn.edu
+16126264565
Thomas Lenarz, Prof.
principal investigator · Hannover Medical School
Amir Samii, Prof.
principal investigator · International Neuroscience Institute Hannover

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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