Industry's First Totally Implantable Hearing Device Uses Solvay's Zeniva® PEEK for Terminal Connectors
Envoy Medical's Esteem® Hearing System Features Biomaterial For Exceptional Insulative and Mechanical Performance
ALPHARETTA, Ga. - Envoy Medical Corp., St. Paul, Minn., has developed the industry's first totally implantable hearing system for moderate to severe sensorineural hearing loss. The Esteem® prosthetic hearing restoration device features two terminal connectors made of Zeniva polyetheretherketone (PEEK) resin from Solvay Specialty Polymers USA, LLC. Zeniva PEEK - part of Solvay's family of Solviva® Biomaterials - provides biocompatibility, strong insulative properties, and excellent mechanical performance.
Unlike hearing aids, the Esteem implantable hearing device does not use a microphone or speaker. Instead, it uses the natural ear drum to detect sound and send a clear message to the brain, via the auditory nerve, by stimulating the cochlea with its prosthetic simulator. Last year, Envoy Medical received pre-market approval (PMA) from the U.S. Food & Drug Administration (FDA) for commercial distribution of the Esteem® implantable hearing device.
"We believe that the Esteem implantable hearing system represents a major breakthrough that provides an alternative to non-implantable and partially implantable hearing aids," said Kevin Verzal, research and development engineer for Envoy Medical. "Zeniva PEEK provides the exceptional properties that are required of a high-precision implant in this critical application."
The innovative design incorporates two terminal connectors (0.1-in by 0.5-in / 2.5 mm by 12.7 mm) for the transducers which are injection molded of Zeniva PEEK. The biomaterial offers better insulative properties and higher mechanical strength than previously used materials like silicone. Zeniva PEEK offers many important benefits including biocompatibility and chemical inertness. Based on biocompatibility testing, Zeniva PEEK demonstrates no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity. It also boasts high strength and stiffness and has radiolucent properties which permit x-ray procedures.
Zeniva PEEK and the entire line of Solviva Biomaterials are manufactured in compliance with the relevant aspects of ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay's biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.
Envoy Medical sells the Esteem implantable hearing device directly to patients. The company matches patients with Envoy-approved surgical centers throughout the U.S. along with its own independently owned surgical center in The Woodlands, Texas.
In addition to ZenivaPEEK, Solvay's line of Solviva Biomaterials includes Proniva self-reinforced polyphenylene (SRP), one of the world's stiffest and strongest unreinforced thermoplastics that offers exceptional biocompatibility and hardness; Veriva polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility; and Eviva polysulfone (PSU), which offers practical toughness in a strong, transparent polymer. These sterilizable products are available in resin for injection molding or extrusion.
About Envoy Medical Corp.
Envoy Medical Corp., based in St. Paul, Minn., is a privately-held company that provides superior value in the field of otology through innovative technology, quality products, continuous improvement, and customer service. The company was originally founded as St. Croix Medical in 1995 to design, manufacture, and market the world's first fully implantable hearing restoration device without a microphone or speaker. Envoy Medical began operations in March 1996 and spent several years developing the breakthrough technology that has become the Esteem® implantable hearing device. For more information, call (651) 361-8000 or visit www.envoymedical.com.
About Solvay Specialty Polymers
Solvay Specialty Polymers manufactures more products with more performance than any other polymer company in the world. The company supplies over 1500 products across 33 brands of high-performance polymers - fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra polymers, high-barrier polymers and cross-linked high-performance compounds - for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil & Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other markets. Learn more at www.solvayspecialtypolymers.com.
Solvay is an international chemical Group committed to sustainable development with a clear focus on innovation and operational excellence. Its recent acquisition of specialty chemicals company Rhodia created a much larger player which is realizing over 90% of its sales in markets where it is among the top 3 global leaders. Solvay offers a broad range of products that contribute to improving quality of life and its customers' performance in markets such as consumer goods, construction, automotive, energy, water and environment, and electronics. The Group is headquartered in Brussels and its companies employ about 30,000 people in 55 countries and generated EUR 12 billion in sales (pro forma) in 2010. Solvay SA is listed on NYSE Euronext (SOLB.BE - Bloomberg: SOLB.BB - Reuters: SOLBt.BR).