Ambispective Clinical Evaluation of Sophono™

CompletedOBSERVATIONAL
Enrollment

71

Participants

Timeline

Start Date

June 29, 2017

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2018

Conditions
Conductive Hearing LossSingle-Sided DeafnessMixed Hearing Loss
Interventions
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."

Trial Locations (6)

10075

Park Avenue Otology/Neurotology, New York

15212

Pittsburgh Ear Associates, Pittsburgh

27609

Carolina Ear & Hearing Clinic, Raleigh

32207

Nemours Children's Specialty Care, Jacksonville

32607

UF Health ENT and Allergy, Gainesville

85006

Macias Otology, Phoenix

All Listed Sponsors
lead

Medtronic Surgical Technologies

INDUSTRY