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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017648

Enrollment

Registered

2021-03-03

Start date

2020-10-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sensorineural hearing loss H90

Interventions

Group 1: Insertion of the hearing contact lens onto the tympanic membrane of one side, insertion of the therewith electrically connected ear-canal retainer module in the bony ear canal. Wearing for 24

Eligibility

Sex/Gender

All

Age

21 Years to No maximum

Inclusion 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

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

Design outcomes

Secondary

Measure	Time frame
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. 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. S3: The system should cause no subjective discomfort or pain in erveryday life for usage >24h.	—

Measure

Time frame

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. 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. S3: The system should cause no subjective discomfort or pain in erveryday life for usage >24h.

—

Primary

Measure	Time frame
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).	—

Countries

Germany

Contacts

Public ContactErnst Dalhoff

HNO-Klinik, Universitätsklinikum Tübingen

ernst.dalhoff@uni-tuebingen.de+49 7071 29988232

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026