CompletedNot Applicable

Ambispective Clinical Evaluation of Sophono™

United States71 participantsStarted 2017-06-29

Plain-language 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.

Who can participate

Age range5 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety Outcome Measure: Proportion of Adverse Events (AEs) Related to Sophono Implant

Timeframe: From Implantation to Study Visit, up to 6 years

Gain in Sensitivity to Sound in Decibels (dB) Resulting From Sophono Alpha 2 Maximum Power Output (MPO) Processor

Timeframe: 1 day

Trial details

NCT IDNCT03143257

SponsorMedtronic Surgical Technologies

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-05-31

Results submitted2019-02-13

View on ClinicalTrials.gov More Conductive Hearing Loss trials