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Intra-Aural Devices for the Treatment of Temporomandibular Joint Disorders


Technology Intra-aural device (marketed under the trade names Cerezen, TMJ Next Generation, TMD Ear System, TMDes, Clayton Intra-Aural Device, or CID)
Manufacturer Not applicable
Focus of Report This report will focus on the use of intra-aural devices for the treatment of temporomandibular joint (TMJ) disorders. It will be used for policy development and to support coverage determinations.
Literature Summary There was a dearth of published literature addressing intraauricular devices for the treatment of TMJ. One abstract for a prospective randomized controlled trial was reviewed.
Regulatory Status One intra-aural device has been cleared through the FDA 510(k) process. The Clayton Intra-aural Device (CID) received 510(k) clearance (K091880) on February 24, 2010 and is indicated as an aid in reducing temporomandibular disorder (TMD) pain.
CE Marking/EMA According to information on the Cerezen European website, Renew Health Limited is the European Union manufacturer that owns the registered CE mark for the CID device.
Payer Coverage Five commercial payers maintain policies that address TMJ; however, only Humana specifically addresses an intra-aural device (i.e., TMJ Next Generation) as a non-covered treatment. No National Coverage Determination (NCD) for intra-aural devices for the treatment of TMJ was identified on the Centers for Medicare & Medicaid Services (CMS) website.
Conclusion Insufficient published evidence to evaluate this technology

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