Preliminary evaluation of a new method to place an EMG electrode into the Stapedius muscle for recording a specific eSRT signal

Phase 1

• Conditions: H90; Conductive and sensorineural hearing loss

• Registration Number: DRKS00019939
• Lead Sponsor: MED-EL Elektromedizinische Geräte GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Age = 18 years
• Measurable acoustical stimulation of the Stapedius reflex
• Need of a cochlear implantation
• Anatomic, physiological and mental conditions compatible with the participation in this clinical Investigation
• High motivation with realistic expectations regarding the participation in this clinical investigation
• Signed and dated informed consent before the start of any investigational procedure

Exclusion Criteria

• Lack of compliance with any inclusion criteria
• Pregnant or breast-feeding women
• Known allergies or intolerance to the material used for this clinical investigation
• Current participation in other drugs and/or medical device clinical investigations that can affect the results of the present clinical investigation
• Other clinical diseases that might result in alteration of the results of this clinical investigation
• Anything that, in the opinion of the Principal Investigator, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this clinical investigation.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following parameters are evaluated:<br>Activation of the stapedius reflex, measured by using <br>• EMG<br>• Video<br>Occurrence of adverse events.