Ambispective Clinical Evaluation of Sophono™
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 5 - Any |
| Updated: | 6/22/2018 |
| Start Date: | June 29, 2017 |
| End Date: | May 31, 2018 |
Study to accumulate post-market clinical evidence for the safety and effectiveness of the
Sophono Alpha 2 and Alpha 2 MPO systems in subjects diagnosed with conductive hearing loss,
single-sided deafness and mixed hearing loss who currently have or have had the Sophono
implant.
Sophono Alpha 2 and Alpha 2 MPO systems in subjects diagnosed with conductive hearing loss,
single-sided deafness and mixed hearing loss who currently have or have had the Sophono
implant.
Inclusion Criteria:
- Any subject who currently has or who has had the Sophono implant (including those who
have been explanted)
- Has or has had Sophono implant for 3 months or longer
Exclusion Criteria:
- Subject has implant but is unable or unwilling to perform audiologic testing
- Subject is currently participating in another clinical study and has not been approved
for concurrent enrollment by the Study Sponsor
We found this trial at
6
sites
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