Auditory Intranerve Stimulation Perceptual Study

NCT07789665 | Recruiting DMC

• 2 other identifiers: 0000509678No.11979-BO-MPDG-M-2025
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Deafness, Perception

Outcome Measures

Primary Outcomes (1)

• Pitch perception performance of ANI

  Systematic place pitch ordering maintained on month 12

  12 months

Secondary Outcomes (1)

• Loudness perception performance of ANI

  12 months

Other Outcomes (3)

• Frequency Resolution

  12 months

• Position of ANI electrode array in auditory nerve

  12 months

• Collection of adverse events

  12 months

Study Arms (1)

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.

Device: Auditory Nerve Implant (ANI)

Interventions

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.

Experimental: Direct Auditory Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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) )
• 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

Sponsors & Collaborators

• Hannover Medical School: lead

Study Sites (2)

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Service provider for the performance of surgical procedures: International Neuroscience Institute

Hanover, 30625, Germany

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Lenarz, Prof.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

• Amir Samii, Prof.

  International Neuroscience Institute Hannover

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hubert Lim, Prof.

CONTACT

+16126264565; Hlim@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 29, 2028
• Study Completion (Estimated): February 29, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

DE (2)