The FDA has issued draft guidance and a proposed rule advising manufacturers how to control risks associated with tinnitus masker devices (TMDs), which treat ringing in the ears.
In its proposed rule, published in the Federal Register, the FDA seeks to amend classification regulations of TMDs, presently classified as Class II, to designate a special control for the devices. The accompanying draft guidance, "Class II Special Controls Guidance Document: Tinnitus Masker Devices," describes a means by which TMDs may comply with the requirement of special controls for Class II devices.
The draft guidance provides information on how to control risks of TMD side effects, including worsening tinnitus, change in hearing, adverse tissue reaction, electrical hazards, tissue heating or cavitation (ultrasound TMDs only), and improper use. The draft guidance contains specific recommendations regarding device performance testing and other information in a 510(k) submission.
Following the effective date of a final rule based on the proposed rule, any firm submitting a 510(k) premarket notification for a TMD device will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness, the FDA said.
The proposed rule is online at http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22269.htm (http://www.fda.gov/OHRMS/DOCKETS/98fr/05-22269.htm). The draft guidance is at http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0344-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0344-gdl0001.pdf).