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Auditory Intranerve Stimulation Perceptual Study

Sponsor: Hannover Medical School • ClinicalTrials.gov ID: NCT07789665

Registry updated: 2026-08-27

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Description

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.

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.

Eligibility criteria

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

Conditions

Deafness, Perception

Locations

Hannover Medical School — Hanover, Germany
Service provider for the performance of surgical procedures: International Neuroscience Institute — Hanover, Germany

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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