Auditory Intranerve Stimulation Study

Hannover Medical School10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Auditory; Nerve

Interventions

Auditory Nerve Acute (ANA) Electrode ArrayOTHER

To measure eABRs when stimulating the human auditory nerve

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hannover Medical School

Hanover, Germany

RECRUITING

Outcomes

Primary Outcomes

Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms

Time frame: 4 weeks

Secondary Outcomes

Collection of adverse events

Time frame: 4 weeks

Central Contacts

Karl-Heinz Dyballa

CONTACT

+4917615328589 dyballa.karl-heinz@mh-hannover.de

Data from ClinicalTrials.gov

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