Ambispective Clinical Evaluation of Sophono™

Completed

Conditions studied: Conductive Hearing Loss, Single-Sided Deafness, Mixed Hearing Loss

In brief

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.

Key facts

Study ID

NCT03143257

Run by

Medtronic Surgical Technologies

People needed

71

Starts

2017-06-29

Expected to finish

2018-05-31

Last updated by the study team

2024-07-05

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Macias Otology — Phoenix, Arizona, United States
• UF Health ENT and Allergy — Gainesville, Florida, United States
• Nemours Children's Specialty Care — Jacksonville, Florida, United States
• Park Avenue Otology/Neurotology — New York, New York, United States
• Carolina Ear & Hearing Clinic — Raleigh, North Carolina, United States
• Pittsburgh Ear Associates — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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