Auditory Intranerve Stimulation Perceptual Study (ANI-NIH)

August 24, 2026 updated by: Hannover Medical School

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hubert Lim, Prof.
  • Phone Number: +16126264565
  • Email: Hlim@umn.edu

Study Locations

  • Germany
      • Hanover, Germany, 30625
        • Recruiting
        • Hannover Medical School
        • Contact:
        • Sub-Investigator:
          • Rolf Salcher, Dr.
        • Sub-Investigator:
          • Max Timm, Dr
        • Sub-Investigator:
          • Waldo Nogueira, Prof.
        • Sub-Investigator:
          • Karl-Heinz Dyballa, Dr.
        • Principal Investigator:
          • Thomas Lenarz, Prof.
      • Hanover, Germany, 30625
        • Active, not recruiting
        • Service provider for the performance of surgical procedures: International Neuroscience Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 and ≤85 years
  2. Written informed consent
  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 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
The investigational research device consists of a speech processor worn on the ear and an implant body with an electrode array.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pitch perception performance of ANI
Time Frame: 12 months
Systematic place pitch ordering maintained on month 12
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Loudness perception performance of ANI
Time Frame: 12 months
Collection of loudness growth functions (LGFs) across single electrodes that have a dynamic range greater than 6 dB and maintained on month 12
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency Resolution
Time Frame: 12 months
Minimum frequency specificity (i.e., current spread) of electrodes is narrower than 0.8 mm in bandwidth maintained on month 12
12 months
Position of ANI electrode array in auditory nerve
Time Frame: 12 months
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.
12 months
Collection of adverse events
Time Frame: 12 months
Collection of adverse events during the evaluation period
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hannover Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas Lenarz, Prof., Hannover Medical School
  • Principal Investigator: Amir Samii, Prof., International Neuroscience Institute Hannover

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 29, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0000509678
  • No.11979-BO-MPDG-M-2025 (Other Identifier: Ethics committee Hannover Medical School)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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