Direct auditory nerve stimulation to see if it can evoke loudness and pitch in adults with severe deafness
Official title: Scientific Assessment of Auditory Intranerve Stimulation Loudness and Pitch Percepts
Run by Hannover Medical School · NCT07789665 · Data updated 2026-11-12
This study tests whether direct stimulation of the auditory nerve with a nerve implant can produce clear loudness and pitch perceptions in adults who can’t use standard cochlear implants.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | Hannover Medical School Academic / other |
| Locations | 2 sites (Hanover and 1 other locations) |
| Status | Recruiting |
| Started | August 2026 |
| Main results expected | February 29, 2028 |
| Study ends | February 29, 2028 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT07789665 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–85 with bilateral deafness where the cochlea cannot support a cochlear implant and who meet surgical and auditory pathway criteria.
✕Probably not a fit
Participants without interpretable auditory nerve responses or with contraindications to surgery may not derive perceptual benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, feasibility study examines direct stimulation of the auditory nerve using an auditory nerve implant (ANI) to elicit percepts such as loudness and pitch in three adults with bilateral deafness. Participants undergo a one-time surgery to place the implant, followed by a structured follow-up over 12 months for healing, device testing, and perceptual assessments. The study compares direct nerve stimulation outcomes with expected perceptual experiences and aims to understand the potential benefits and limitations of ANI technology. The primary aim is to gain scientific insight into hearing perception with direct auditory nerve stimulation, which could inform future implant designs. No efficacy claims are made; results will inform feasibility and perceptual correlates of ANI use.
Why it matters
Potential benefit: If successful, participants may experience clearer or more natural sound percepts from direct nerve stimulation, informing future hearing restoration options.
How similar studies have gone: Preclinical and early clinical data suggest potential perceptual advantages from direct auditory nerve stimulation, but human data remain limited and exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hannover Medical School
Hanover, Germany Recruiting -
Service provider for the performance of surgical procedures: International Neuroscience Institute
Hanover, Germany Active not recruiting
Study contacts
- Principal investigator: Thomas Lenarz, Prof. — Hannover Medical School
- Study coordinator: Hubert Lim, Prof.
- Email: Hlim@umn.edu
- Phone: +16126264565
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.