Envoy Esteem Totally Implantable Hearing System Phase 2 Trial, 1-Year Hearing Results

• Published in: Otolaryngology-head and neck surgery Vol. 145; no. 1; pp. 100 - 109
• Main Authors: Kraus, Eric M., Shohet, Jack A., Catalano, Peter J.
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01-07-2011
• Subjects: Adolescent; Adult; Aged; Ear Ossicles - surgery; Equipment Safety; Facial Paralysis - etiology; Female; Follow-Up Studies; Hearing Aids - adverse effects; Hearing Loss, Sensorineural - rehabilitation; Humans; Male; Middle Aged; Prosthesis Design; Prosthesis Fitting; Prosthesis Implantation - adverse effects; Reoperation; Speech Discrimination Tests; Speech Reception Threshold Test; Surgical Wound Infection - etiology; Temporal Bone - surgery; Transducers; Young Adult; sensorineural hearing loss; transducer; phase 2 clinical trial; laser Doppler vibrometer; glass-ionomer cement; fully implantable; Esteem; piezoelectric; totally implantable hearing system; US Food and Drug Administration approval; driver; sound processor; Envoy Medical Corporation; Envoy; middle ear device; sensor
• ISSN: 0194-5998; 1097-6817
• DOI: 10.1177/0194599811401709

Objectives. (1) To assess outcomes of the Envoy Esteem Totally Implantable Hearing System as measured by hearing results compared with preimplant baseline unaided (BLU) and best-fit aided conditions (BLA) and (2) to determine safety of the device.
Study Design. Prospective, nonrandomized, multicenter, subject-as-own-control, US Food and Drug Administration (FDA) trial.
Setting. Private practice and hospital-based.
Subjects and Methods. Between January 2008 and August 2009, an FDA trial was performed at 3 sites. Fifty-seven subjects with bilateral, mild to severe sensorineural hearing loss, with discrimination greater than 40%, were implanted. Implanted components were (1) a sound processor and (2) 2 piezoelectric transducers (a sensor and a driver). A sound processor was implanted in the temporal bone. Transducers were coupled to the ossicles. Devices were activated 2 months postimplant. Hearing results were compared with ipsilateral BLU and BLA.
Results. Speech reception thresholds (SRTs) improved from BLA of 41.2 dB to 29.4 dB with the Esteem (P ≤ .001). Word recognition score (WRS) at 50 dB hearing level (HL) improved from BLA of 46.3% to 68.9% with the Esteem. Pure tone averages improved by 27 ± 1 dB (confidence interval, 30-25). There were no changes in bone conduction. QuickSIN results showed no change. There were 6 serious adverse device effects: 2 wound infections (1 resolved medically, 1 required explantation), 1 delayed facial paralysis that resolved with medication, and 3 revisions due to limited benefit.
Conclusion. Phase 2 results at 12 months post implant demonstrated that (1) hearing results with the device are statistically superior to baseline best-fit hearing aids for SRT and WRS and (2) the device is safe.