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 range

5 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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