Food and Drug Administration, HHS 801 - nchalb.org

1 food and drug administration , HHS it is labeled for use as a germicide or states audiologists must satisfy spe- deodorizer. cific requirements for licensure. (d) This section does not affect the (5) Sale or purchase includes any lease present threshold limit value of or rental of a hearing aid to a member part per million ( milligram per of the consuming public who is a user cubic meter) of ozone exposure for an 8- or prospective user of a hearing aid. hour-day exposure of industrial work- (6) Used hearing aid means any hear- ers as recommended by the American ing aid that has been worn for any pe- Conference of Governmental Industrial riod of time by a user. However, a hear- Hygienists. ing aid shall not be considered used''.

2 (e) The method and apparatus speci- merely because it has been worn by a fied in 40 CFR part 50, or any other prospective user as a part of a bona fide equally sensitive and accurate method, hearing aid evaluation conducted to de- may be employed in measuring ozone termine whether to select that par- pursuant to this section. ticular hearing aid for that prospective user, if such evaluation has been con- Chlorofluorocarbon propel- ducted in the presence of the dispenser lants. or a hearing aid health professional se- The use of chlorofluorocarbon in de- lected by the dispenser to assist the vices as propellants in self-pressurized buyer in making such a determination. containers is generally prohibited ex- (b) Label requirements for hearing aids.

3 Cept as provided in of this chap- Hearing aids shall be clearly and per- ter. manently marked with: (1) The name of the manufacturer or [43 FR 11318, Mar. 17, 1978] distributor, the model name or num- ber, the serial number, and the year of Hearing aid devices; profes- manufacture. sional and patient labeling. (2) A +'' symbol to indicate the posi- (a) Definitions for the purposes of this tive connection for battery insertion, section and (1) Hearing aid unless it is physically impossible to in- means any wearable instrument or de- sert the battery in the reversed posi- vice designed for, offered for the pur- tion. pose of, or represented as aiding per- (c) Labeling requirements for hearing sons with or compensating for, im- aids (1) General.

4 All labeling informa- paired hearing. tion required by this paragraph shall (2) Ear specialist means any licensed be included in a User Instructional physician who specializes in diseases of Brochure that shall be developed by the ear and is medically trained to the manufacturer or distributor, shall identify the symptoms of deafness in accompany the hearing aid, and shall the context of the total health of the be provided to the prospective user by patient, and is qualified by special the dispenser of the hearing aid in ac- training to diagnose and treat hearing cordance with (c). The User In- loss. Such physicians are also known as structional Brochure accompanying otolaryngologists, otologists, and each hearing aid shall contain the fol- otorhinolaryngologists.

5 Lowing information and instructions (3) Dispenser means any person, part- for use, to the extent applicable to the nership, corporation, or association en- particular requirements and character- gaged in the sale, lease, or rental of istics of the hearing aid: hearing aids to any member of the con- (i) An illustration(s) of the hearing suming public or any employee, agent, aid, indicating operating controls, user sales person, and/or representative of adjustments, and battery compart- such a person, partnership, corpora- ment. tion, or association. (ii) Information on the function of all (4) Audiologist means any person controls intended for user adjustment. qualified by training and experience to (iii) A description of any accessory specialize in the evaluation and reha- that may accompany the hearing aid, bilitation of individuals whose commu- , accessories for use with a tele- nication disorders center in whole or in vision or telephone.

6 Part in the hearing function. In some (iv) Specific instructions for: 27. VerDate 11<MAY>2000 00:15 Apr 20, 2001 Jkt 194069 PO 00000 Frm 00027 Fmt 8010 Sfmt 8010 Y:\SGML\ pfrm01 PsN: 194069T. 21 CFR Ch. I (4 1 01 Edition). (a) Use of the hearing aid. hearing aid if the hearing aid dispenser de- (b) Maintenance and care of the hear- termines through inquiry, actual observa- ing aid, including the procedure to fol- tion, or review of any other available infor- mation concerning the prospective user, that low in washing the earmold, when re- the prospective user has any of the following placing tubing on those hearing aids conditions: that use tubing, and in storing the (i) Visible congenital or traumatic deform- hearing aid when it will not be used for ity of the ear.

7 An extended period of time. (ii) History of active drainage from the ear (c) Replacing or recharging the bat- within the previous 90 days. teries, including a generic designation (iii) History of sudden or rapidly progres- of replacement batteries. sive hearing loss within the previous 90 days. (v) Information on how and where to (iv) Acute or chronic dizziness. obtain repair service, including at least (v) Unilateral hearing loss of sudden or re- one specific address where the user can cent onset within the previous 90 days. (vi) Audiometric air-bone gap equal to or go, or send the hearing aid to, to ob- greater than 15 decibels at 500 hertz (Hz), tain such repair service. 1,000 Hz, and 2,000 Hz.

8 (vi) A description of commonly oc- (vii) Visible evidence of significant ceru- curring avoidable conditions that could men accumulation or a foreign body in the adversely affect or damage the hearing ear canal. aid, such as dropping, immersing, or (viii) Pain or discomfort in the ear. exposing the hearing aid to excessive Special care should be exercised in select- heat. ing and fitting a hearing aid whose max- (vii) Identification of any known side imum sound pressure level exceeds 132 deci- bels because there may be risk of impairing effects associated with the use of a the remaining hearing of the hearing aid hearing aid that may warrant con- user. (This provision is required only for sultation with a physician, , skin those hearing aids with a maximum sound irritation and accelerated accumula- pressure capability greater than 132 decibels tion of cerumen (ear wax).)

9 (dB).). (viii) A statement that a hearing aid (3) Notice for prospective hearing aid will not restore normal hearing and users. The User Instructional Brochure will not prevent or improve a hearing shall contain the following notice: impairment resulting from organic conditions. IMPORTANT NOTICE FOR PROSPECTIVE HEARING. (ix) A statement that in most cases AID USERS. infrequent use of a hearing aid does not Good health practice requires that a per- permit a user to attain full benefit son with a hearing loss have a medical eval- from it. uation by a licensed physician (preferably a (x) A statement that the use of a physician who specializes in diseases of the hearing aid is only part of hearing ha- ear) before purchasing a hearing aid.

10 Li- bilitation and may need to be supple- censed physicians who specialize in diseases mented by auditory training and in- of the ear are often referred to as struction in lipreading. otolaryngologists, otologists or otorhinolaryngologists. The purpose of med- (xi) The warning statement required ical evaluation is to assure that all medi- by paragraph (c)(2) of this section. cally treatable conditions that may affect (xii) The notice for prospective hear- hearing are identified and treated before the ing aid users required by paragraph hearing aid is purchased. (c)(3) of this section. Following the medical evaluation, the phy- (xiii) The technical data required by sician will give you a written statement that paragraph (c)(4) of this section, unless states that your hearing loss has been medi- such data is provided in separate label- cally evaluated and that you may be consid- ered a candidate for a hearing aid.