Cochlear*s Direct Acoustic Cochlear Stimulator Investigational Device (C-DACS ID) clinical trial CAG5229

Phase 2

Completed

Conditions: fixation of the stapes
Otosclerosis
10019243

Registration Number: NL-OMON34163

Lead Sponsor: Cochlear AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

1. Eighteen years of age or older
2. Mixed severe to profound hearing loss
3. Conductive hearing loss is a result of otosclerosis or prior failed stapes surgery
4. Bone conduction thresholds are worse than 40 dB HL on at least 3 out of 5 frequencies (500 Hz, 1 kHz, 2 kHz, 3 kHz and 4 kHz) but must be measurable at all five frequencies
5. Bone conduction thresholds equal to or greater than 30 dB HL in all frequencies
6. Air-bone gap equal to or greater than 30 dB HL on at least 3 out of 5 frequencies
7. Bone conduction of contra-lateral ear is equal to or worse than 30 dB HL at the best frequency

Exclusion Criteria

1. Participation in another medical device study
2. Unwillingness or inability of the subject to comply with all study requirements
3. Bone conduction threshold exceeds 80 dB HL at 1 or more out of 5 frequencies (500 Hz, 1 kHz, 2 kHz, 3 kHz and 4 kHz)
4. Air conduction threshold exceeds 120 dB HL at 1 or more out of 5 frequencies
(500 Hz, 1 kHz, 2 kHz, 3 kHz and 4 kHz)
5. Medical or psychological conditions that would contraindicate undergoing surgery
6. Sudden hearing loss
7. Disabling tinnitus
8. Insufficient mastoid and/or ear canal size (to be checked on CT scan)
9. Other criteria at investigator*s discretion

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Audiological: aided free field hearing thresholds and scores of speech<br /><br>discrimination.<br /><br>Chirurgisch: complication registration and bone conduction thresholds.<br /><br>The subjective experiences of the participants will be tested by the APHAB<br /><br>questionnaire. </p><br>

Secondary Outcome Measures