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(4) In any medical condition for which there is no proof of safety and effectiveness.

(5) To generate ozone at a level less than 0.05 part per million by volume of air circulating through the device and it is labeled for use as a germicide or deodorizer.

(d) This section does not affect the present threshold limit value of 0.10 part per million (0.2 milligram per cubic meter) of ozone exposure for an 8hour-day exposure of industrial workers as recommended by the American Conference of Governmental Industrial Hygienists.

(e) The method and apparatus specified in 40 CFR part 50, or any other equally sensitive and accurate method, may be employed in measuring ozone pursuant to this section.

8801.417 Chlorofluorocarbon propel

lants. The use of chlorofluorocarbon in devices as propellants in self-pressurized containers is generally prohibited except as provided in $2.125 of this chapter.

(4) Audiologist means any person qualified by training and experience to specialize in the evaluation and rehabilitation of individuals whose communication disorders center in whole or in part in the hearing function. In some states audiologists must satisfy specific requirements for licensure.

(5) Sale or purchase includes any lease or rental of a hearing aid to a member of the consuming public who is a user or prospective user of a hearing aid.

(6) Used hearing aid means any hearing aid that has been worn for any period of time by a user. However, a hearing aid shall not be considered "used” merely because it has been worn by a prospective user as a part of a bona fide hearing aid evaluation conducted to determine whether to select that particular hearing aid for that prospective user, if such evaluation has been conducted in the presence of the dispenser or a hearing aid health professional selected by the dispenser to assist the buyer in making such a determination.

(b) Label requirements for hearing aids. Hearing aids shall be clearly and permanently marked with:

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

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

(c) Labeling requirements for hearing aids-(1) General. All labeling information required by this paragraph shall be included in a User Instructional Brochure that shall be developed by the manufacturer or distributor, shall accompany the hearing aid, and shall be provided to the prospective user by the dispenser of the hearing aid in accordance with 8801.421(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:

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

(43 FR 11318, Mar. 17, 1978]

8801.420 Hearing aid devices; profes

sional and patient labeling. (a) Definitions for the purposes of this section and $ 801.421. (1) Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.

(2) Ear specialist means any licensed physician who specializes in diseases of the ear and is medically trained to identify the symptoms of deafness in the context of the total health of the patient, and is qualified by special training to diagnose and treat hearing loss. Such physicians are also known as otolaryngologists, otologists, and otorhinolaryngologists.

(3) Dispenser means any person, partnership, corporation, or association engaged in the sale, lease, or rental of hearing aids to any member of the consuming public or any employee, agent, sales person, and/or representative of such a person, partnership, corporation, or association.

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

(iii) A description of any accessory that may accompany the hearing aid, e.g., accessories for use with a television or telephone.

(iv) Specific instructions for: (a) Use of the hearing aid.

(6) 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.

(c) Replacing or recharging the batteries, including a generic designation of replacement batteries.

(v) 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.

(vi) A description of commonly OCcurring avoidable conditions that could adversely affect or damage the hearing aid, such as dropping, immersing, or exposing the hearing aid to excessive heat.

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

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

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

(x) 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 lipreading.

(xi) The warning statement required by paragraph (c)(2) of this section.

(xii) The notice for prospective hearing aid users required by paragraph (c)(3) of this section.

(xiii) The technical data required by paragraph (c)(4) of this section, unless such data is provided in separate labeling accompanying the device.

(2) Warning statement. 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 prospective user, that the prospective user has any of the following conditions:

(i) Visible congenital or traumatic deformity of the ear.

(ii) History of active drainage from the ear within the previous 90 days.

(iii) History of sudden or rapidly progressive hearing loss within the previous 90 days.

(iv) Acute or chronic dizziness.

(v) Unilateral hearing loss of sudden or recent onset within the previous 90 days.

(vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.

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

(viii) Pain or discomfort in the ear.

Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds 132 deci. bels 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 132 decibels (dB).)

(3) Notice for prospective hearing aid users. 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.

Following the medical evaluation, the physician will give you a written statement that states that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or a

hearing aid dispenser, as appropriate, for a and Records Administration (NARA). hearing aid evaluation.

For information on the availability of The audiologist or hearing aid dispenser

this material at NARA, call 202–741– will conduct a hearing aid evaluation to assess your ability to hear with and without a

6030, or go to: http://www.archives.gov/ hearing aid. The hearing aid evaluation will

federal_register/ enable the audiologist or dispenser to select code of_federal regulations/ and fit a hearing aid to your individual ibr locations.html. As a minimum, the needs.

User Instructional Brochure or such If you have reservations about your ability

other labeling shall include the approto adapt to amplification, you should inquire

priate values or information for the about the availability of a trial-rental or

following technical data elements as purchase-option program. Many hearing aid dispensers now offer programs that permit

these elements are defined or used in you to wear a hearing aid for a period of such

such standard: time for a nominal fee after which you may (i) Saturation output curve (SSPL 90 decide if you want to purchase the hearing curve). aid.

(ii) Frequency response curve. Federal law restricts the sale of hearing

(iii) Average saturation output (HFaids to those individuals who have obtained

Average SSPL 90). a medical evaluation from a licensed physi

(iv) Average full-on gain (HF-Average cian. Federal law permits a fully informed adult to sign a waiver statement declining

full-on gain). the medical evaluation for religious or per

(v) Reference test gain. sonal beliefs that preclude consultation with (vi) Frequency range. a physician. The exercise of such a waiver is (vii) Total harmonic distortion. not in your best health interest and its use (viii) Equivalent input noise. is strongly discouraged.

(ix) Battery current drain. CHILDREN WITH HEARING LOSS

(x) Induction coil sensitivity (tele

phone coil aids only). In addition to seeing a physician for a med

(xi) Input-output curve (ACG aids ical evaluation, a child with a hearing loss

only). should be directed to an audiologist for evaluation and rehabilitation since hearing loss

(xii) Attack and release times (ACG may cause problems in language develop aids only). ment and the educational and social growth (5) Statement if hearing aid is used or of a child. An audiologist is qualified by rebuilt. If a hearing aid has been used or training and experience to assist in the eval rebuilt, this fact shall be declared on uation and rehabilitation of a child with a

the container in which the hearing aid hearing loss.

is packaged and on a tag that is phys(4) Technical data. Technical data ically attached to such hearing aid. useful in selecting, fitting, and check- Such fact may also be stated in the ing the performance of a hearing aid User Instructional Brochure. shall be provided in the User Instruc (6) Statements in User Instructional tional Brochure or in separate labeling Brochure other than those required. A that accompanies the device. The de- User Instructional Brochure may contermination of technical data values tain statements or illustrations in adfor the hearing aid labeling shall be dition to those required by paragraph conducted in accordance with the test (c) of this section if the additional procedures of the American National statements: Standard “Specification of Hearing Aid (i) Are not false or misleading in any Characteristics," ANSI S3.22–1996 (ASA particular, e.g., diminishing the impact 70–1996) (Revision of ANSI S3.22–1987), of the required statements; and which is incorporated by reference in (ii) Are not prohibited by this chapaccordance with 5 U.S.C. 552(a) and 1 ter or by regulations of the Federal CFR part 51. Copies are available from Trade Commission. the Standards Secretariat of the (d) Submission of all labeling for each Acoustical Society of America, 120 type of hearing aid. Any manufacturer Wall St., New York, NY 10005-3993, or of a hearing aid described in paragraph are available for inspection at the Reg (a) of this section shall submit to the ulations Staff, CDRH (HFZ-215), FDA, Food and Drug Administration, Bureau 1350 Piccard Dr., rm. 240, Rockville, MD of Medical Devices and Diagnostic 20850, and or at the National Archives Products, Division of Compliance,

th

HFK-116, 8757 Georgia Ave., Silver hearing aid to a prospective user, the Spring, MD 20910, a copy of the User In- hearing aid dispenser shall: structional Brochure described in para (1) Provide the prospective user a graph (c) of this section and all other copy of the User Instructional Brolabeling for each type of hearing aid on chure for a hearing aid that has been, or before August 15, 1977.

or may be selected for the prospective (42 FR 9294, Feb. 15, 1977, as amended at 47

user; FR 9398, Mar. 5, 1982; 50 FR 30154, July 24, (2) Review the content of the User In1985; 54 FR 52396, Dec. 21, 1989; 64 FR 59620, structional Brochure with the prospecNov. 3, 1999; 69 FR 18803, Apr. 9, 2004]

tive user orally, or in the predominate

method of communication used during 8801.421 Hearing aid devices; condi. tions for sale.

(3) Afford the prospective user an op(a) Medical evaluation requirements portunity to read the User Instruc(1) General. Except as provided in para- tional Brochure. graph (a)(2) of this section, a hearing (c) Availability of User Instructional aid dispenser shall not sell a hearing Brochure. (1) Upon request by an indiaid unless the prospective user has pre vidual who is considering purchase of a sented to the hearing aid dispenser a hearing aid, a dispenser shall, with rewritten statement signed by a licensed spect to any hearing aid that he disphysician that states that the patient's penses, provide a copy of the User Inhearing loss has been medically evalu structional Brochure for the hearing ated and the patient may be considered aid or the name and address of the a candidate for a hearing aid. The med manufacturer or distributor from ical evaluation must have taken place whom a User Instructional Brochure within the preceding 6 months.

for the hearing aid may be obtained. (2) Waiver to the medical evaluation re- (2) In addition to assuring that a User quirements. If the prospective hearing Instructional Brochure accompanies aid user is 18 years of age or older, the each hearing aid, a manufacturer or hearing aid dispenser may afford the distributor shall with respect to any prospective user an opportunity to hearing aid that he manufactures or waive the medical evaluation require distributes: ment of paragraph (a)(1) of this section

(i) Provide sufficient copies of the provided that the hearing aid dis

User Instructional Brochure to sellers penser:

for distribution to users and prospec(i) Informs the prospective user that

tive users; the exercise of the waiver is not in the

(ii) Provide a copy of the User Inuser's best health interest;

structional Brochure to any hearing (ii) Does not in any way actively en

aid professional, user, or prospective courage the prospective user to waive

user who requests a copy in writing. such a medical evaluation; and

(d) Recordkeeping. The dispenser shall (iii) Affords the prospective user the

retain for 3 years after the dispensing opportunity to sign the following

of a hearing aid a copy of any written statement:

statement from a physician required I have been advised by

under paragraph (a)(1) of this section (Hearing aid dispenser's name) that the Food or any written statement waiving medand Drug Administration has determined ical evaluation required under parathat my best health interest would be served graph (a)(2)(iii) of this section. if I had a medical evaluation by a licensed

(e) Exemption for group auditory trainphysician (preferably a physician who spe

ers. Group auditory trainers, defined as cializes in diseases of the ear) before purchasing a hearing aid. I do not wish a med

a group amplification system purical evaluation before purchasing a hearing chased by a qualified school or instituaid.

tion for the purpose of communicating

with and educating individuals with (b) Opportunity to review User Instruc

hearing impairments, are exempt from tional Brochure. Before signing any

the requirements of this section. statement under paragraph (a)(2)(iii) of this section and before the sale of a [42 FR 9296, Feb. 15, 1977]

$ 801.430 User labeling for menstrual (4) Avoiding the risk of getting tamtampons.

pon-associated TSS by not using tam(a) This section applies to scented or

pons, and reducing the risk of getting scented deodorized menstrual tampons

TSS by alternating tampon use with as identified in $ 884.5460 and unscented

sanitary napkin use during menstrual menstrual tampons as identified in

periods; and $ 884.5470 of this chapter.

(5) The need to seek medical atten(b) Data show that toxic shock syn

tion before again using tampons if TSS drome (TSS), a rare but serious and

warning signs have occurred in the sometimes fatal disease, is associated

past, or if women have any questions with the use of menstrual tampons. To

about TSS or tampon use. protect the public and to minimize the

(e) The statements required by paraserious adverse effects of TSS, men

graph (e) of this section shall be promistrual tampons shall be labeled as set

nently and legibly placed on the packforth in paragraphs (c), (d), and (e) of

age label of menstrual tampons in conthis section and tested for absorbency

formance with section 502(c) of the as set forth in paragraph (f) of this sec

Federal Food, Drug, and Cosmetic Act tion.

(the act) (unless the menstrual tam(c) If the information specified in

pons are exempt under paragraph (g) of paragraph (d) of this section is to be in

this section). cluded as a package insert, the fol

(1) Menstrual tampon package labels lowing alert statement shall appear shall bear one of the following absorbprominently and legibly on the pack

ency terms representing the absorbage label:

ency of the production run, lot, or

batch as measured by the test deATTENTION: Tampons are associated with

scribed in paragraph (f)(2) of this secToxic Shock Syndrome (TSS). TSS is a rare

tion; but serious disease that may cause death. Read and save the enclosed information.

Ranges of absorbency in Corresponding term of abgrams'

sorbency (d) The labeling of menstrual tampons shall contain the following con 6 and under

Light absorbency sumer information prominently and

6 to 9

Regular absorbency legibly, in such terms as to render the information likely to be read and un 9 to 12

Super absorbency derstood by the ordinary individual

12 to 15

Super plus absorbency under customary conditions of purchase and use:

15 to 18

Ultra absorbency (1)(i) Warning signs of TSS, e.g., sud

No term

Above 18 den fever (usually 102° or more) and vomiting, diarrhea, fainting or near These ranges are defined, respectively, as follows: Less

than or equal to 6 grams (g); greater than 6 g up to and infainting when standing up, dizziness, or

cluding 9 g; greater than 9 g up to and including 12 g; greater a rash that looks like a sunburn;

than 12 g up to and including 15 g; greater than 15 g up to (ii) What to do if these or other signs

and including 18 g; and greater than 18 g. of TSS appear, including the need to (2) The package label shall include an remove the tampon at once and seek explanation of the ranges of absorbmedical attention immediately;

ency and a description of how con(2) The risk of TSS to all women sumers can use a range of absorbency, using tampons during their menstrual and its corresponding absorbency term, period, especially the reported higher to make comparisons of absorbency of risks to women under 30 years of age tampons to allow selection of the tamand teenage girls, the estimated inci pons with the minimum absorbency dence of TSS of 1 to 17 per 100,000 men needed to control menstrual flow in struating women and girls per year, order to reduce the risk of contracting and the risk of death from contracting TSS. TSS;

(f) A manufacturer shall measure the (3) The advisability of using tampons absorbency of individual tampons using with the minimum absorbency needed the test method specified in paragraph to control menstrual flow in order to (f)(2) of this section and calculate the reduce the risk of contracting TSS; mean absorbency of a production run,

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