This study seeks to assess the efficacy of the Envoy Esteem totally implantable hearing device in treating profound high-frequency sensorineural hearing loss.
Five patients with profound high-frequency hearing loss participating in a prospective, multi-center, nonrandomized Food and Drug Administration clinical trial.
Implantation with Esteem totally implantable hearing device and comparison to baseline unaided and aided conditions.
Speech reception threshold and word recognition scores (WRS) at 50 dB HL presentation level.
Preoperative speech reception threshold improved from an unaided 65 dB and aided 48 dB average to 26 dB with the Esteem at 12 months. WRS at 50 dB scores improved from an unaided 10% and aided 23% average to 78% postoperatively.
The Esteem totally implantable middle ear hearing device provides appreciable functional gain and improvement in WRS to rehabilitate hearing in patients with a profound high-frequency sensorineural hearing loss.
*Shohet Ear Associates, Newport Beach, California; †The Ear Center of Greensboro, P.A., Greensboro, North Carolina; and ‡The Lahey Clinic, Burlington, Massachusetts, U.S.A. (Dr. Catalano is currently affiliated with St. Elizabeth’s Hospital, Boston, Massachusetts, U.S.A.)
Address correspondence and reprint requests to Jack A. Shohet, M.D., 446 Old Newport Blvd., Newport Beach, CA 92663; E-mail: JShohet@eardoctor.org
Article Presentation: This article was presented at the 2010 AAO-HNSF Annual Meeting and Oto Expo, Scientific Oral Presentations, Boston, MA, September 29, 2010.
Sponsorship: Envoy Medical Corporation, St. Paul, MN, provided funding and support for the research and statistical analysis for the FDA Phase II Pivotal Trial and the European CE Mark Trial. Envoy Medical Corporation did not provide funding for preparation of the manuscript.
Financial Disclosures: During the research study upon which the manuscript is based, Dr. Shohet served as a clinical coinvestigator, surgical consultant, and Medical Advisory Board Member for Envoy Medical Corporation. Neither he, nor any member of his family, has any financial interest in the company or competing interests. During the research study upon which the manuscript is based, Dr. Kraus served as a clinical coinvestigator, surgical consultant, and Medical Advisory Board Member (MAB) for Envoy Medical Corporation. At the time of article submission, he no longer serves as a surgical consultant or MAB member. Neither he, nor any member of his family, has any financial interest in the company or competing interests.