Auditory; Nerve
Conditions
Brief summary
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.
Interventions
OTHERAuditory Nerve Acute (ANA) Electrode Array
To measure eABRs when stimulating the human auditory nerve
Sponsors
Hannover Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elicit a typical eABR Wave V with at least 0.2 µV in amplitude and a latency of the peak around 5 ms | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Collection of adverse events | 4 weeks |
Countries
Germany
Contacts
Primary ContactKarl-Heinz Dyballa
Outcome results
None listed