Auditory Intranerve Stimulation Study

Not Applicable

Recruiting

• Conditions: Auditory; Nerve
• Interventions: Other: Auditory Nerve Acute (ANA) Electrode Array

• Registration Number: NCT06306534
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-15
• Status Verified: 2024-02
• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insert Array Into Auditory Nerve	Auditory Nerve Acute (ANA) Electrode Array	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Collection of adverse events	4 weeks

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany