21 C.F.R. § 801.422

Current through September 30, 2024

Section 801.422 - Prescription hearing aid labeling

(a)Scope. This section specifies the labeling requirements for prescription hearing aids. Any hearing aid that does not satisfy the requirements of § 800.30 of this chapter shall be a prescription device. Unless otherwise specified, the requirements in this section are in addition to other applicable requirements, including but not limited to special controls found in the applicable classification regulation in part 874 of this chapter. This section does not apply to group auditory trainers.

(b)Definitions for the purposes of this section. This section uses the following definitions:

Dispenser. A dispenser is any person, as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of hearing aids to any member of the consuming public or any employee, agent, salesperson, and/or representative of such a person.

Hearing aid. A hearing aid is any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.

Prescription hearing aid. A prescription hearing aid is a hearing aid that is not an over-the-counter (OTC) hearing aid as defined in § 800.30 of this chapter or a hearing aid that does not satisfy the requirements in § 800.30 of this chapter.

Rebuilt hearing aid. A prescription hearing aid is "rebuilt" if the manufacturer has inspected and tested the device, made any necessary modifications to ensure it meets applicable regulatory requirements, including the requirements in this section, and adequately reprocessed the device for the next user.

Sale. Sale includes a lease, rental, or any other purchase or exchange for value.

Used hearing aid. A hearing aid is "used" if a user has worn it for any period of time. However, a hearing aid shall not be "used" merely because a prospective user wore it as part of a bona fide hearing aid evaluation to determine whether to select that particular hearing aid for that prospective user. A hearing aid evaluation is "bona fide" if it was conducted in the presence of the dispenser or a hearing health professional selected by the dispenser to assist the prospective user in making a determination.

(c)Labeling. A prescription hearing aid shall bear all of the following labeling:

(1)Outside package labeling. The outside package of a prescription hearing aid shall bear all of the following:

(i)Warnings and other important information. All of the following shall appear on the outside package:

(A)Warning against use in people younger than 18 without prior medical evaluation.

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(B)"Red flag" conditions.

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(C)Note about device trial options.

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(ii)Statement of build condition. If the prescription hearing aid is used or rebuilt, the outside package shall declare that fact. A sticker under and visible through the outer wrapper will suffice to declare such fact.

(iii)Indication of battery information. The outside package shall indicate the type and number of batteries and whether batteries are included in the package.

(iv)Indication of control platform. That outside package shall indicate whether a mobile device or other non-included control platform is required. The indication must include the type of platform and how the platform connects to the device.

(2)Labeling, inside the package. The manufacturer or distributor of a prescription hearing aid shall include a user instructional brochure inside the package and shall make an electronic version available for download without site or customer registration and without requiring purchase of any product or service. The user instructional brochure shall include all of the following:

(i) The following warnings, which shall appear in the following order and prior to any content except the cover page:

(A)Warning against use in people younger than 18 without prior medical evaluation.

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(B)"Red flag" conditions, addressed to dispensers.

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(C)Warning to dispensers about very high-output devices.

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(D)Additional warnings. Any additional warnings the manufacturer may include prior to the cautions and notices to users in paragraph (c)(2)(ii) of this section.

(ii) The following cautions and notices for users, which shall appear prior to any content, except the cover page and the warnings under paragraph (c)(2)(i) of this section:

(A)Caution about hearing protection.

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(B)Caution about excessive sound output.

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(C)Caution about components lodging in ear.

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(D)Note about user expectations.

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(E)Note about reporting adverse events to FDA.

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(F)Note about hearing loss in people younger than 18 and fitting devices.

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(iii) An illustration(s) of the prescription hearing aid that indicates operating controls, user adjustments, and the battery compartment.

(iv) Information on the function of all controls intended for user adjustment.

(v) A description of any accessory that accompanies the prescription hearing aid, including but not limited to wax guards, and accessories for use with a computer, television, or telephone.

(vi) Specific instructions for all of the following:

(A) Use of the prescription hearing aid with any accompanying accessories.

(B) Maintenance and care of the prescription hearing aid, including how a user can clean, disinfect, and replace parts or how to seek replacements, as well as how to store the hearing aid when it will not be used for an extended period of time.

(C) If the battery is replaceable or rechargeable, how to replace or recharge the battery, including a generic designation of replacement batteries.

(D) Expected battery life.

(vii) Identification of any known physiological side effects associated with the use of the prescription hearing aid that may warrant consultation with a physician, referring to an ear-nose-throat doctor when preferable, including if applicable, skin irritation and accelerated accumulation of cerumen (ear wax).

(viii) The technical specifications required by paragraph (c)(4) of this section unless such specifications appear in separate labeling accompanying the prescription hearing aid.

(ix) A description of commonly occurring, avoidable events that could adversely affect or damage the prescription hearing aid, including but not limited to, as applicable, ear wax buildup, drops, immersion in water, or exposure to excessive heat.

(x) If the hearing aid incorporates wireless technology in its programming or use, appropriate warnings, instructions, and information relating to electromagnetic compatibility and wireless technology and human exposure to non-ionizing radiation.

(xi) Information on how and where to obtain repair service or replacements, including at least one specific address where the user can go or send the prescription hearing aid to obtain such repair service or replacements.

(xii) If clinical or non-clinical studies were conducted by or for the manufacturer to support the performance of the prescription hearing aid, a summary of all such studies.

(3)Labeling on the device. The labeling on a prescription hearing aid itself shall bear all of the following clearly and permanently, except as provided in paragraph (c)(3)(iii) of this section:

(i) The serial number.

(ii) If the battery is removable, a "+" symbol to indicate the positive terminal for battery insertion unless the battery's physical design prevents inserting the battery in the reversed position.

(iii) If the prescription hearing aid is used or rebuilt, the manufacturer shall physically attach a removable tag to the hearing aid declaring that fact.

(4)Technical specifications. You must determine the technical specification values for the prescription hearing aid labeling in accordance with the test procedures of ANSI/ASA S3.22-2014 (R2020), except as provided in paragraph (c)(4)(ix) of this section for latency. Technical specifications and their associated values that are useful in selecting, fitting, and checking the performance of the prescription hearing aid shall appear in the user instructional brochure or in separate labeling that accompanies the device, including all of the following:

(i) Saturation output curve (Saturation Sound Pressure Level (SSPL) 90 curve).

(ii) Frequency response curve.

(iii) Average saturation output (High Frequency (HF)-Average SS PL 90 ).

(iv) Average full-on gain (HF-Average full-on gain).

(v) Reference test gain.

(vi) Frequency range.

(vii) Total harmonic distortion.

(viii) Equivalent input noise.

(ix) Latency, measured using a method that is accurate and repeatable to within 1.5 ms.

(x) Battery current drain.

(xi) Induction coil sensitivity (telephone coil aids only).

(xii) Input-output curve (only for hearing aids with automatic gain control).

(xiii) Attack and release times (only for hearing aids with automatic gain control).

(5)Software device labeling. Prescription hearing aid software that is not distributed with the hearing aid or amplification platform shall meet all of the following labeling requirements. With respect to the information required under paragraphs (c)(1) through (4) of this section, the information must be provided in the software device labeling, as specified in paragraphs (c)(5)(i) through (v) of this section, rather than the locations (e.g., outside package labeling) specified in paragraphs (c)(1) through (4).

(i) Prior to first use of the software or obtaining payment information for the software, whichever occurs first, the labeling must clearly and prominently present all of the following to the prospective user. For each, the labeling must remain visible until the user dismisses it or proceeds to the next step:

(A) Compatibility and minimum operating requirements for the software device.

(B) Disclosures of any fees or payments after first use or initial payment, including but not limited to any fees or payments relating to subscriptions, add-on features, or continued access to features or services. The disclosures must name and briefly describe what each fee or payment covers.

(C) The information required under paragraphs (c)(1)(i) and (iv) of this section.

(ii) Prior to first use of the software, the labeling must clearly and prominently present all of the following to the prospective user:

(A) The information required under paragraph (c)(2)(i)(A) of this section, and it must remain visible until the user acknowledges it.

(B) The information required under paragraphs (c)(2)(i)(B) through (D) and (c)(2)(ii), (iv), (vii), and (viii) of this section, and the information must remain visible until the user dismisses it or proceeds to the next step.

(C) All other information required under paragraph (c)(2) of this section, to the extent applicable, and the information must remain visible until the user dismisses it or proceeds to the next step.

(iii) The software device labeling must include the information required under paragraphs (c)(3)(i) and (c)(4) of this section.

(iv) All of the software device labeling must be accessible for review after acknowledgment, dismissal, or proceeding to the next step.

(v) If there are changes to any of the labeling required under paragraph (c)(5) of this section, the labeling with the changed information must be presented to the user until the user dismisses it.

(6)Misbranding. A prescription hearing aid that is not labeled as required under this section and § 801.109 is misbranded under sections 201(n), 502(a), and/or 502(f) of the Federal Food, Drug, and Cosmetic Act.

(d)Incorporation by reference. ANSI/ASA S3.22-2014 (R2020), "AMERICAN NATIONAL STANDARD Specification of Hearing Aid Characteristics," dated June 5, 2020, is incorporated by reference into this section with the approval of the Director of the Office of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. This material is available for inspection at the Food and Drug Administration and at the National Archives and Records Administration (NARA). Contact the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. For information on the availability of this material at NARA, email: fr.inspection@nara.gov, or go to: www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from the Acoustical Society of America (ASA), 1305 Walt Whitman Road, Suite 300, Melville, NY 11747; phone: (631) 390-0215; fax: (631) 923-2875; email: asastds@acousticalsociety.org.

21 C.F.R. §801.422

87 FR 50755, Aug. 17, 2022

87 FR 50755, 10/17/2022