N/A
Completed N=71
Ambispective Clinical Evaluation of Sophono™
Source: ClinicalTrials.gov NCT03143257 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant — 0.038 Proportion of Adverse Events
Summary
Study to accumulate post-market clinical evidence for the safety and effectiveness of the Sophono Alpha 2 and Alpha 2 Maximum Power Output (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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant |
0.038 | — |
| PRIMARY Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor |
79.1; 41.2; 39.4; 35.7 | <0.0001 sig |
| SECONDARY Compare the Effectiveness of the Sophono Alpha 2 Processor to the Alpha 2 MPO Processor |
70.9; 33.5; 39.5; 36.0 | — |
| SECONDARY Percentage of Participants Satisfied After System Use |
63; 74; 79 | — |
| SECONDARY Assess QOL After System Use |
25.4; 49.1; 32.4; 53.7; 33.0; 63.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03143257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.