10322 HEARING AID DEVICES: PROFESSIONAL AND PATIENT LABELING

10322.1 Hearing aids shall be clearly and permanently marked with:

(a) The name of the manufacturer or distributor, the model name or number, the serial number, and the year of manufacture; and

(b) A "+" symbol to indicate the positive connection for battery insertion, unless it is physically impossible to insert the battery in the reversed position.

10322.2 All labeling information required by this section shall be included in a User Instructional Brochure that the manufacturer or distributor develops, shall accompany the hearing aid, and shall be provided to the prospective user by the dispenser of the hearing aid in accordance with 21 C.F.R. § 801.421(c). The User Instructional Brochure accompanying each hearing aid shall contain the following information and instructions for use, to the extent applicable to the particular requirements and characteristics of the hearing aid:

(a) An illustration(s) of the hearing aid, indicating operating controls, user adjustments, and battery compartment;

(b) Information on the function of all controls intended for user adjustment;

(c) A description of any accessory that may accompany the hearing aid (for example, accessories for use with a television or telephone);

(d) Specific instructions for:

(1) Use of the hearing aid;

(2) Maintenance and care of the hearing aid, including the procedure to follow in washing the earmold, when replacing tubing on those hearing aids that use tubing, and in storing the hearing aid when it will not be used for an extended period of time; and

(3) Replacing or recharging the batteries, including a generic designation of replacement batteries;

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

(f) A description of commonly occurring avoidable conditions that could adversely affect or damage the hearing aid, such as dropping, immersing in liquid, or exposing the hearing aid to excessive heat;

(g) Identification of any known side effects associated with the use of hearing aid that may warrant consultation with a physician, e.g., skin irritation and accelerated accumulation of cerumen (ear wax);

(h) A statement that a hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions;

(i) A statement that in most cases infrequent use of a hearing aid does not permit a user to attain full benefit from it;

(j) A statement that the use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lip-reading;

(k) The warning statement required by § 10322.3;

(l) The notice for prospective hearing aid users required by § 10322.4; and

(m) The technical data required by § 10322.5, unless such data is provided in separate labeling accompanying the device.

10322.3 The User Instructional Brochure shall contain the following warning statement:

WARNING TO HEARING AID DISPENSERS

A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the following conditions:

(a) Visible congenital or traumatic deformity of the ear;

(b) History of active drainage from the ear within the previous ninety (90) days;

(c) History of sudden or rapidly progressive hearing loss within the previous ninety (90) days;

(d) Acute or chronic dizziness;

(e) Unilateral hearing loss of sudden or recent onset within the previous ninety (90) days;

(f) Audiometric air-bone gap equal to or greater than fifteen decibels (15 dB) at five hundred hertz (500 Hz), one thousand hertz (1,000 Hz), and two thousand hertz (2,000 Hz);

(g) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal; or

(h) Pain or discomfort in the ear.

Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds one hundred thirty-two decibels (132 dB) because there may be risk of impairing the remaining hearing of the hearing aid user. (This provision is required only for those hearing aids with a maximum sound pressure capability greater than one hundred thirty-two decibels (132 dB)."

10322.4 The User Instructional Brochure shall contain the following notice:

IMPORTANT NOTICE FOR PROSPECTIVE HEARING AID USERS

Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otologists, or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased.

CHILDREN WITH HEARING LOSS

In addition to seeing a physician for a medical evaluation, a child with hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss.

10322.5 Technical data useful in selecting, fitting, and checking the performance of a hearing aid shall be provided in the User Instructional Brochure or in separate labeling that accompanies the device. The determination of technical data values

for the hearing aid labeling shall be conducted in accordance with the test procedures of the American National Standard "Specification of Hearing Aid Characteristics," ANSI S3.22-2003 (Revision of ANSI S3.22-19106) (includes April 2007 Erratum). At a minimum, the User Instructional Brochure or such other labeling shall include the appropriate values or information for the following technical data elements as these elements are defined or used in such standard:

1. (a) Saturation output curve (SSPL 90 curve);
2. (b) Frequency response curve;
3. (c) Average saturation output (HF-Average SSPL 90);
4. (d) Average full-on gain (HF-Average full-on gain);
5. (e) Reference test gain;
6. (f) Frequency range;
7. (g) Total harmonic distortion;
8. (h) Equivalent input noise;
9. (i) Battery current drain;
10. (j) Induction coil sensitivity (telephone coil aids only);
11. (k) Input-output curve (automatic gain control aids only); or
12. (l) Attack and release times (ACG aids only).

10322.6 If a hearing aid has been used or rebuilt, this fact shall be declared on the container in which the hearing aid is packaged and on a tag that is physically attached to the hearing aid. Such fact may also be stated in the User Instructional Brochure.

10322.7 A User Instructional Brochure may contain statements or illustrations in addition to those required by § 10322.2 if the additional statements:

1. (a) Are not false or misleading in any particular (for example, diminishing the impact of the required statements); and
2. (b) Are not prohibited by this chapter or by regulations.

SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).