Auditory Intranerve Stimulation Perceptual Study (ANI-NIH)

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: Recruiting
• Conditions: Deafness, Perception
• Intervention / Treatment: Device: Auditory Nerve Implant (ANI)

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: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hubert Lim, Prof.; Phone Number: +16126264565; Email: Hlim@umn.edu

Study Locations

• Germany
  • Hanover, Germany, 30625
    • Recruiting
    • Hannover Medical School
    • Contact: Karl-Heinz Dyballa; Phone Number: +4917615328589; Email: dybala.karl-heinz@mh-hannover.de
    • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pitch perception performance of ANI	Systematic place pitch ordering maintained on month 12	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency Resolution	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	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	Collection of adverse events during the evaluation period	12 months

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Thomas Lenarz, Prof., Hannover Medical School; Principal Investigator: Amir Samii, Prof., International Neuroscience Institute Hannover

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: August 12, 2026
• First Submitted That Met QC Criteria: August 24, 2026
• First Posted (Actual): August 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Sensorineural
• Other Study ID 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