DevicePMAs@therightstef:P990052_S015 JSONTXT 11 Projects

Approval for a change in the wording of the indications for use statement and a new product code description that removes the reference to hearing aids. The device is indicated for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids.