Auditory Intranerve Stimulation Study (AIS)

Hannover Medical School (MHH)

Status: Enrolling

Conditions: Auditory; Nerve

Treatments: Other: Auditory Nerve Acute (ANA) Electrode Array

Study type: Interventional

Funder types: Other

Identifiers

NCT06306534

CIV-22-05-039592 (Other Grant/Funding Number)

AIS-001

Details and patient eligibility

About

This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent
2. Patients who will undergo an acoustic neuroma removal surgery and are functional deaf
3. Age ≥ 18 years
4. Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists

Exclusion criteria

1. Disabilities in addition to hearing impairment which might interfere with the study procedure
2. Pregnant and breast feeding woman or other vulnerable population

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Insert Array Into Auditory Nerve

Experimental group

Treatment:

Other: Auditory Nerve Acute (ANA) Electrode Array