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

Phase 1

• Conditions: sensorineural hearing loss; H90; Conductive and sensorineural hearing loss

• Registration Number: DRKS00017648
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-11-19
• Study Start: 2021-03-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The usable frequency range of sound amplification shall be extended from up to 6 kHz for conventional hearing aids to 10 kHz (maximum equivalent sound pressure >= 100 dB SPL up to 3 kHz and 90 dB SPL up to 10 kHz with 1 Vrms drive voltage).

Secondary Outcome Measures

Name	Time	Method
S1: Under local surface anesthesia of the external ear canal and the tympanic membrane, insertion of the system and its removal should be feasable within 15 min., without injury of external ear canal and tympanic membrane and without impairment of the inner ear, notably with respect to hearing ability. Assessment of hearing ability: Comparison of hearing threshold and distortion product emission threshold post removal versus before insertion of the tympanic membrane contact. <br>S2: The user should be able to connect the behind-the-ear module with the in-the-canal retainer with the magnetic connector without altering position of the in-the-canal retainer and the tympanic membrane contact.<br>S3: The system should cause no subjective discomfort or pain in erveryday life for usage >24h.