Phase III results with a totally implantable piezoelectric middle ear implant: speech audiometry, spatial hearing and psychosocial adjustment.

Objective: To evaluate the treatment efficacy of an electromechanical middle ear amplifier implant (AI) in patients with chronic moderate-to-severe sensorineural hearing loss (SNHL). The AI is a piezoelectric system with a sound processor and a rechargeable battery within a hermetically sealed titanium canister. Its titanium-sealed microphone is placed in the bony region of the ear canal.

Patient selection for incus body coupling of a totally implantable middle ear implant.

Objective: To evaluate audiologic selection criteria for incus body coupling (IBC) of a totally implantable middle ear implant (TI-MEI) for the treatment of sensorineural hearing loss (SNHL).

Material And Methods: The protocol is specified in the Investigational Device Exemption of a Food and Drug Administration-approved multicenter clinical trial. The prospective study compared pre- and postoperative hearing levels using each patient as their own control.