Auditory Intranerve Stimulation Perceptual Study
Key facts
- Where
- Hanover, GermanySee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07789665, who can take part
Where in Germany
- Hannover Medical SchoolHanover, GermanyContact: Karl-Heinz DyballaTaking people
- Service provider for the performance of surgical procedures: International Neuroscience InstituteHanover, GermanyContact: Hubert Lim, Prof.No longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hannover Medical School
- Trial code
- NCT07789665
- Record updated
- 27 August 2026
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Other active devices with potential interference with the auditory nerve implant; Medical, neurological, or psychological conditions that would contraindicate undergoing surgery, e.g. depression, acute cardiac infarction, history of stroke, dementia, epilepsy; 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) ); 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; 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.