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Clinical Trials/DRKS00019939
DRKS00019939
Completed
Phase 1

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

MED-EL Elektromedizinische Geräte GmbH0 sites18 target enrollmentMarch 3, 2020

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
H90
Sponsor
MED-EL Elektromedizinische Geräte GmbH
Enrollment
18
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 3, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
MED-EL Elektromedizinische Geräte GmbH

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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