Source: https://www.federalregister.gov/documents/2019/10/28/2019-23464/medical-devices-ear-nose-and-throat-devices-classification-of-the-self-fitting-air-conduction
Timestamp: 2020-04-09 01:36:13
Document Index: 165250680

Matched Legal Cases: ['art 874', 'art 807', 'art 807', 'art 820', 'art 814', 'art 807', 'art 801', 'art 874', 'art 874', '§\u2009874', '§\u2009874']

Federal Register :: Medical Devices; Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid
This order is effective October 28, 2019. The classification was applicable on October 5, 2018.
84 FR 57610
57610-57612 (3 pages)
Docket No. FDA-2019-N-4328
2019-23464
FDA-2019-N-4328
List of Subjects in 21 CFR Part 874
https://www.federalregister.gov/d/2019-23464 https://www.federalregister.gov/d/2019-23464
The Food and Drug Administration (FDA or we) is classifying the self-fitting air-conduction hearing aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the self-fitting air-conduction hearing aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Cherish Giusto, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2432, Silver Spring, MD 20993-0002, 301-796-9679, Cherish.Giusto@fda.hhs.gov.
Upon request, FDA has classified the self-fitting air-conduction hearing aid as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a Start Printed Page 57611determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the 510(k) process, when necessary, to market their device.
On May 11, 2018, Bose Corp. submitted a request for De Novo classification of the Bose Hearing Aid. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
Therefore, on October 5, 2018, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 874.3325. We have named the generic type of device self-fitting air-conduction hearing aid, and it is identified as a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings.
Table 1—Self-Fitting Air-Conduction Hearing Aid Risks and Mitigation Measures
Diminished hearing due to over-amplification caused by: • Excessively high sound output levels in the ear canal • Device malfunction • Interference with or from other devices Software verification, validation, and hazard analysis; Electroacoustic performance testing; and Electromagnetic compatibility (EMC) testing.
Listening fatigue or failure to provide sound awareness due to over- or under-amplification caused by: • Poor fitting • Device malfunction • Use error • Interference with or from other devices Clinical data; Usability testing; Software verification, validation, and hazard analysis; Electroacoustic performance testing; EMC testing; and Labeling
Tissue heating due to exposure to non-ionizing radiation emitted by wireless technology Wireless technology evaluation; and Labeling.
Tissue trauma/damage in the ear canal or other patient contacting areas due to: Usability testing; Electrical and thermal safety testing; and Labeling.
• Excessively long ear piece
Missed or delayed medical diagnosis or treatment due to failure to self-identify correct population and condition Labeling.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 814, subparts A through E, regarding Start Printed Page 57612premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 874 is amended as follows:
1. The authority citation for part 874 continues to read as follows:
2. Add § 874.3325 to subpart D to read as follows:
§ 874.3325
Self-fitting air-conduction hearing aid.
(a) Identification. A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings.
(1) Clinical data must evaluate the effectiveness of the self-fitting strategy.
(2) Electroacoustic parameters, including maximum output limits, distortion levels, self-generated noise levels, latency, and frequency response, must be specified and tested.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device.
(5) If the device incorporates wireless technology:
(i) Performance testing must validate safety of exposure to non-ionizing radiation;
(ii) Performance data must validate wireless technology functions; and
(iii) Labeling must specify instructions, warnings, and information relating to wireless technology and human exposure to non-ionizing radiation.
(6) Usability testing must demonstrate that users can correctly use the device as intended under anticipated conditions of use.
(7) Patient labeling must include the following:
(i) Information on how a patient can self-identify as a candidate for the device;
(ii) Information about when to seek professional help;
(iii) A warning about using hearing protection in loud environments;
(iv) A warning about staying alert to sounds around the user of the device;
(v) Technical information about the device, including information about EMC; and
(vi) Information on how to correctly use and maintain the device.
[FR Doc. 2019-23464 Filed 10-25-19; 8:45 am]