21 CFR §874.3315

1. (a)Identification. A tympanic membrane contact hearing aid is a prescription wearable device that compensates for impaired hearing. Amplified sound is transmitted by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane. A tympanic membrane contact hearing aid is subject to the requirements in § 801.422 of this chapter.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)The patient contacting components must be demonstrated to be biocompatible.
   2. (2)Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and must include:
      1. (i)Mechanical integrity testing;
      2. (ii)Electrical and thermal safety testing;
      3. (iii)Software verification, validation, and hazard analysis;
      4. (iv)Reliability testing consistent with expected device life;
      5. (v)Electromagnetic compatibility testing; and
      6. (vi)Validation testing of device output and mechanical force applied to the tympanic membrane in a clinically appropriate model.
   3. (3)Clinical performance testing must characterize any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.
   4. (4)Professional training must include the ear impression procedure, correct placement, fitting, monitoring, care, and maintenance of the device.
   5. (5)Labeling must include the following:
      1. (i)A detailed summary of the adverse events and effectiveness outcomes from the clinical performance testing;
      2. (ii)Detailed instructions on how to fit the device to the patient;
      3. (iii)Instructions for periodic cleaning of any reusable components;
      4. (iv)Information related to electromagnetic compatibility; and
      5. (v)Patient labeling that includes:
         1. (A)A patient card that identifies if a patient has been fitted with any non-self- removable components of the device and provides relevant information in cases of emergency;
         2. (B)Information on how to correctly use and maintain the device;
         3. (C)The potential risks and benefits associated with the use of the device; and
         4. (D)Alternative treatments.