NCT03143257

Ambispective Clinical Evaluation of Sophono™

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: Medtronic Surgical Technologies · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: —

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.

Conditions

• Conductive Hearing Loss
• Single-Sided Deafness
• Mixed Hearing Loss

Interventions

Type	Name	Description
DEVICE	Sophono Bone Conduction Hearing Systems	The Sophono Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of Bone Conduction (BC) of sound vibrations. The Sophono Bone Conduction Hearing Systems transmits audio vibrations through the skin into the bone where sound is sensed by the inner ear/cochlea. The Sophono Sound Processor is magnetically attracted to the Magnetic Implant and Magnetic Spacer. The Magnetic Implant, which is secured to the skull bone, affixes the Magnetic Spacer to the head transcutaneously through magnetic attraction forces, and the Sound Processor is magnetically affixed to the Magnetic Spacer. Vibration from the Sound Processor is transduced through the Magnetic Spacer to the Magnetic Implant and through the bone to the inner ear.

Timeline

• Start date: 2017-06-29
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2017-05-08
• Last updated: 2024-07-05
• Results posted: 2024-07-05

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study