Specialty: Surgery, Primary sub-specialty: ENT Surgery
Conditions
Interventions
Once participants have been given enough time to process the study and the information provided on the information sheet the Surgeon will consent the patient. After this the patient has a pre-operativ
Sponsors
University Hospitals Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient satisfaction is measured using the Health Utilities Index (HUI) is administered between 2-4 weeks operation, the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire and a study specific questionnaire that has been created for the SIME study along with the HUI 2 and 6 months after the operation 2. Microphone sensitivity will be measured by obtaining sound field thresholds in the sound field by using warble tones with the speaker positioned at 00azimuth relative to the subject’s head. Measurements will be done at standard audiometric frequencies (250, 500, 750, 1000, 2000, 3000, 4000, 6000 Hz) using a standard audiometric technique (5 dB steps). This assessment will be carried out 4,8,12 and 16 weeks after the surgery. 3. Noise floor and speech understanding will be measured by English BKB sentences and AB words in the sound field using recorded speech and a standard audiometric technique with the speaker positioned at 00 azimuth relative to the subject’s head. Word recognition scores will be measured at 45, 55 and 65 and 75 dB SPL, representing soft, conversational and loud presentation levels. This test is done with both quiet and noise in the sound fields. The speech intelligibility level in the presence of noise is used when assessing in a noise sound field. This assessment will be carried out 4,8,12 and 16 weeks after the surgery. 4. Perception of body noise are measured using bone conduction measurements using a bone conductor and a standard audiometric technique (5 dB steps) 4,8,12 and 16 weeks after the surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactAmy Gosling
Outcome results
None listed