---
kind: "section"
citation: "21 C.F.R. § 874.3315"
title: "21"
number: "874.3315"
heading: "Tympanic membrane contact hearing aid."
url: "https://uscodex.org/cfr/21/874.3315"
---

# §874.3315. Tympanic membrane contact hearing aid.

- (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](/cfr/21/801.422.md) of this chapter.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The patient contacting components must be demonstrated to be biocompatible.
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, and must include:
    - (i) Mechanical integrity testing;
    - (ii) Electrical and thermal safety testing;
    - (iii) Software verification, validation, and hazard analysis;
    - (iv) Reliability testing consistent with expected device life;
    - (v) Electromagnetic compatibility testing; and
    - (vi) Validation testing of device output and mechanical force applied to the tympanic membrane in a clinically appropriate model.
  - (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) Professional training must include the ear impression procedure, correct placement, fitting, monitoring, care, and maintenance of the device.
  - (5) Labeling must include the following:
    - (i) A detailed summary of the adverse events and effectiveness outcomes from the clinical performance testing;
    - (ii) Detailed instructions on how to fit the device to the patient;
    - (iii) Instructions for periodic cleaning of any reusable components;
    - (iv) Information related to electromagnetic compatibility; and
    - (v) **Patient labeling that includes—**
      - (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;
      - (B) Information on how to correctly use and maintain the device;
      - (C) The potential risks and benefits associated with the use of the device; and
      - (D) **Alternative treatments.**

## Notes

### Amendments

[81 FR 3326, Jan. 21, 2015, as amended at 87 FR 50762, Aug. 17, 2022]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[81 FR 3326, Jan. 21, 2015, as amended at 87 FR 50762, Aug. 17, 2022]