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Clinical Trials/DRKS00017648
DRKS00017648
Completed
Phase 1

Optimization of an active tympanic membrane contact lens for future hearing solutions

niversitätsklinikum Tübingen0 sites7 target enrollmentMarch 3, 2021
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Conditionssensorineural hearing lossH90Conductive and sensorineural hearing loss

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
sensorineural hearing loss
Sponsor
niversitätsklinikum Tübingen
Enrollment
7
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 3, 2021
End Date
November 19, 2020
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversitätsklinikum Tübingen

Eligibility Criteria

Inclusion Criteria

  • •1\) Age \>\= 21;
  • •2\) normal otoscopic finding;
  • •3\) average pure\-tone threshold PTA4 \<\= 45 dB HL, pure\-tone threshold \<\=75 dB HL at 6 and 8 kHz;
  • •4\) air\-bone gap \<\= 10 dB;
  • •5\) Informed consent signed by participant;
  • •6\) Subject able to understand pertinent information and provide informed consent

Exclusion Criteria

  • •1\) Acute pathology of middle\- and/or inner ear (otitis media, labyrinthitis, sudden hearing loss);
  • •2\) Chronic hearing impairment: Otosclerosis, chronic otitis media mesotympanalis;
  • •3\) history yof middle\-ear surgery;
  • •4\) ear canal length outside the range specified in the IFU;
  • •5\) No available size of the ICR (in\-the\-canal retainer) well tolerable for the study participant;
  • •6\) Subjects with active implants

Outcomes

Primary Outcomes

Not specified

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