Human feasibility study of an implantable middle ear microphone

Not Applicable

Completed

• Conditions: Specialty: Surgery, Primary sub-specialty: ENT Surgery; UKCRC code/ Disease: Ear/ Diseases of middle ear and mastoid; Ear, Nose and Throat; Hearing loss

• Registration Number: ISRCTN98453768
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust

Brief Summary

2022 Results article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7613807/ (added 14/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-04
• Study Completion: 2019-03-31
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Aged 18 years and over
2. Fluent native speaker in language used to assess speech perception, i.e. English
3. Regular use of CI for minimum of 12 months
4. Speech performance criteria of at least 50% on BKB sentences in quiet with the CI at a presentation level of 70 dBA.
5. Willingness to have percutaneous plug and microphone implanted
6. Ability and willingness to perform audiometric tests and complete the study
7. Willingness to use the implanted microphone during the study outside the clinic in daily life environment.
8. Ability to provide useful feedback about the usage of the implanted microphone
9. Normal tympanometry.
10. No clinical, audiological or radiological evidence of abnormal ossicular chain

Exclusion Criteria

1. Prelingually deafened adults
2. Active chronic otitis media
3. Participation in another medical device study
4. Unwillingness or inability of the subject to comply with all study requirements
5. Persons with mental, physical or geographic limitations that may render them incapable of completing scheduled study visits
6. Unrealistic expectations on the part of the subject regarding the possible benefits, risks and limitations inherent to the procedure and the device
7. Medical conditions that would contraindicate undergoing surgery or participation in the study
8. Any anticipated reason why removal of the implanted microphone could not be conducted after eight months of use.
9. Known risks to infection and healing
10. Known reason for requiring Magnetic Resonance Imaging (MRI) during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified