Section § 2539.1

Explanation

If you're an audiologist in California and want to sell hearing aids, you need a special license called a dispensing audiology license. To get this license, you must apply, pay fees, and pass a specific exam. If you already have a license to sell hearing aids before 2010, you can keep using it until it expires. After that, you'll automatically meet the new requirements. However, if your license to sell hearing aids is revoked or suspended, you can't sell them anymore and must meet all the new conditions. Audiologists who dispense hearing aids can choose to hold both types of licenses if they wish. Hearing aid dispensers with the right qualifications can easily transition to getting a dispensing audiology license.

(a)Copy CA Business & Professions Code § 2539.1(a)
(1)Copy CA Business & Professions Code § 2539.1(a)(1) On and after January 1, 2010, in addition to satisfying the licensure and examination requirements described in Sections 2532, 2532.2, and 2532.25, no licensed audiologist shall sell hearing aids unless they complete an application for a dispensing audiology license, pay all applicable fees, and pass an examination, approved by the board, relating to selling hearing aids.
(2)CA Business & Professions Code § 2539.1(a)(2) The board shall issue a dispensing audiology license to a licensed audiologist who meets the requirements of paragraph (1).
(b)Copy CA Business & Professions Code § 2539.1(b)
(1)Copy CA Business & Professions Code § 2539.1(b)(1) On and after January 1, 2010, a licensed audiologist with an unexpired license to sell hearing aids pursuant to Article 8 (commencing with Section 2538.10) may continue to sell hearing aids pursuant to that license until that license expires pursuant to Section 2538.53, and upon that expiration the licensee shall be deemed to have satisfied the requirements described in subdivision (a) and may continue to sell hearing aids pursuant to their audiology license subject to this chapter. Upon the expiration of the audiologist’s license to sell hearing aids, the board shall issue them a dispensing audiology license pursuant to paragraph (2) of subdivision (a). This paragraph shall not prevent an audiologist who also has a hearing aid dispenser license from maintaining dual or separate licenses if they choose to do so.
(2)CA Business & Professions Code § 2539.1(b)(2) A licensed audiologist whose license to sell hearing aids, issued pursuant to Article 8 (commencing with Section 2538.10), is suspended, surrendered, or revoked shall not be authorized to sell hearing aids pursuant to this subdivision and they shall be subject to the requirements described in subdivision (a) and the other provisions of this chapter.
(c)CA Business & Professions Code § 2539.1(c) A licensed hearing aid dispenser who meets the qualifications for licensure as an audiologist shall be deemed to have satisfied the requirements of paragraph (1) of subdivision (a) for the purposes of obtaining a dispensing audiology license.
(d)CA Business & Professions Code § 2539.1(d) For purposes of subdivision (a), the board shall provide the hearing aid dispenser examination provided by the former Hearing Aid Dispensers Bureau until the next examination validation and occupational analysis is completed by the Department of Consumer Affairs pursuant to Section 139 and a determination is made that a different examination is to be administered.

Section § 2539.10

Explanation

If you're an audiologist selling hearing aids, you must keep detailed records of each sale for seven years. These records should include test results related to the hearing aid fitting, and relevant written notices and receipts as specified by other laws.

A licensed dispensing audiologist shall, upon the consummation of a sale of a hearing aid, keep and maintain records in the licensed dispensing audiologist’s office or place of business at all times and each such record shall be kept and maintained for a seven-year period. These records shall include:
(a)CA Business & Professions Code § 2539.10(a) Results of test techniques as they pertain to fitting of the hearing aid.
(b)CA Business & Professions Code § 2539.10(b) A copy of the written notice and the written receipt required by Section 2539.4 and the written recommendation and receipt required by Section 2539.6, when applicable.

Section § 2539.12

Explanation

If you're a licensed audiologist who owns or manages a place where hearing aids are sold or fitted, you're responsible for making sure that the hearing aids sold or fitted by anyone else at your location are up to standard.

A licensed audiologist who is the owner, manager, or franchisee at a location where hearing aids are fit or sold, shall be responsible for the adequacy of the fitting or selling of any hearing aid fit and sold by any licensee or licensees at that location.

Section § 2539.14

Explanation

This law says that some specific rules normally applying to audiologists don't apply if the audiologist meets the conditions outlined in another set of rules found in Section 2539.1.

The provisions of subdivisions (b) and (c) of Section 2538.11 and the provisions of Section 2538.12 do not apply to a licensed audiologist who satisfies the requirements of Section 2539.1.

Section § 2539.2

Explanation

This law allows the sale of hearing aids through catalog or direct mail only if certain conditions are met. The person selling the hearing aids must be a licensed audiologist in California and cannot provide any advice on fitting or selecting the hearing aids. Additionally, a signed statement from a doctor, audiologist, or licensed hearing aid dispenser must confirm compliance with a specific requirement (Section 2539.6), and the seller must keep this statement on file for a set period as outlined in another section (Section 2539.10).

(a)CA Business & Professions Code § 2539.2(a) Hearing aids may be sold by catalog or direct mail provided that:
(1)CA Business & Professions Code § 2539.2(a)(1) The seller is licensed as an audiologist in this state and is authorized to sell hearing aids pursuant to Section 2539.1.
(2)CA Business & Professions Code § 2539.2(a)(2) There is no fitting, selection, or adaptation of the instrument and no advice is given with respect to fitting, selection, or adaptation of the instrument and no advice is given with respect to the taking of an ear impression for an earmold by the seller.
(3)CA Business & Professions Code § 2539.2(a)(3) The seller has received a statement which is signed by a physician and surgeon, audiologist, or a hearing aid dispenser, licensed by the State of California which verifies that Section 2539.6 has been complied with.
(b)CA Business & Professions Code § 2539.2(b) A copy of the statement referred to in paragraph (3) of subdivision (a) shall be retained by the seller for the period provided for in Section 2539.10.

Section § 2539.4

Explanation

If you are buying a hearing aid from a licensed audiologist in California, and that hearing aid uses special programming software, the audiologist must give you a written notice before the sale. This notice must be in large print and let you know that the hearing aid can only be serviced in certain locations. You have to sign this notice, and the audiologist keeps a copy.

After you buy the hearing aid, the audiologist has to give you a receipt with details like the date of the sale, the make and model of the hearing aid, their business address and service hours, whether the hearing aid is used or new, and any warranty information. They'll also include licensing info for all involved in the sale.

(a)CA Business & Professions Code § 2539.4(a) To the extent not inconsistent with federal law, a licensed dispensing audiologist shall, before the consummation of a sale of a hearing aid that uses proprietary programming software or locked, nonproprietary programming software, provide the purchaser with a written notice in 12-point type or larger that states the following: “The hearing aid being purchased uses proprietary or locked programming software and can only be serviced or programmed at specific facilities or locations.” The written notice shall be signed by the purchaser before the sale. The licensed dispensing audiologist shall keep and maintain a copy of the notice in accordance with Section 2539.10.
(1)CA Business & Professions Code § 2539.4(a)(1) For purposes of this subdivision, the following definitions apply:
(A)CA Business & Professions Code § 2539.4(a)(1)(A) “Proprietary programming software” means software used to program hearing aids that is supplied by a hearing aid distributor or manufacturer for the exclusive use by affiliated providers. This software is locked and inaccessible to nonaffiliated providers.
(B)CA Business & Professions Code § 2539.4(a)(1)(B) “Locked, nonproprietary programming software” means software that any provider can render inaccessible to other hearing aid programmers.
(b)CA Business & Professions Code § 2539.4(b) A licensed dispensing audiologist shall, upon the consummation of a sale of a hearing aid, deliver to the purchaser a written receipt, signed by or on behalf of the licensed dispensing audiologist, containing all of the following:
(1)CA Business & Professions Code § 2539.4(b)(1) The date of consummation of the sale.
(2)CA Business & Professions Code § 2539.4(b)(2) Specifications as to the make, serial number, and model number of the hearing aid or aids sold.
(3)CA Business & Professions Code § 2539.4(b)(3) The address of the principal place of business of the licensed dispensing audiologist, and the address and office hours at which the licensed dispensing audiologist shall be available for fitting or postfitting adjustments and servicing of the hearing aid or aids sold.
(4)CA Business & Professions Code § 2539.4(b)(4) A statement to the effect that the aid or aids delivered to the purchaser are used or reconditioned, as the case may be, if that is the fact.
(5)CA Business & Professions Code § 2539.4(b)(5) The number of the licensed dispensing audiologist’s license and the name and license number of any other hearing aid dispenser, temporary licensee, or audiologist who provided any recommendation or consultation regarding the purchase of the hearing aid.
(6)CA Business & Professions Code § 2539.4(b)(6) The terms of any guarantee or written warranty, required by Section 1793.02 of the Civil Code, made to the purchaser with respect to the hearing aid or hearing aids.

Section § 2539.6

Explanation

If certain ear-related conditions are observed, an audiologist must advise the person in writing to see a physician specializing in ear diseases before a hearing aid is sold or fitted. These conditions include ear deformities, recent drainage, quick hearing loss, dizziness, one-sided hearing loss, air-bone gap, excessive earwax, or ear pain. However, this advice isn't needed if a hearing aid is simply being replaced within a year of purchase. The written advice and related documents must be kept by the audiologist for a specified period, but this requirement does not mean the audiologist is diagnosing illness or practicing medicine.

(a)CA Business & Professions Code § 2539.6(a) Whenever any of the following conditions are found to exist either from observations by the licensed audiologist or on the basis of information furnished by the prospective hearing aid user, a licensed audiologist shall, prior to fitting or selling a hearing aid to any individual, suggest to that individual in writing that the individual’s best interests would be served if they consult a licensed physician and surgeon specializing in diseases of the ear or, if none are available in the community, a duly licensed physician and surgeon:
(1)CA Business & Professions Code § 2539.6(a)(1) Visible congenital or traumatic deformity of the ear.
(2)CA Business & Professions Code § 2539.6(a)(2) History of, or active, drainage from the ear within the previous 90 days.
(3)CA Business & Professions Code § 2539.6(a)(3) History of sudden or rapidly progressive hearing loss within the previous 90 days.
(4)CA Business & Professions Code § 2539.6(a)(4) Acute or chronic dizziness.
(5)CA Business & Professions Code § 2539.6(a)(5) Unilateral hearing loss of sudden or recent onset within the previous 90 days.
(6)CA Business & Professions Code § 2539.6(a)(6) Significant air-bone gap (when generally acceptable standards have been established).
(7)CA Business & Professions Code § 2539.6(a)(7) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
(8)CA Business & Professions Code § 2539.6(a)(8) Pain or discomfort in the ear.
(b)CA Business & Professions Code § 2539.6(b) No referral for medical opinion need be made by any licensed audiologist in the instance of replacement only of a hearing aid that has been lost or damaged beyond repair within one year of the date of purchase. A copy of the written recommendation shall be retained by the licensed audiologist for the period provided for in Section 2539.10. A person receiving the written recommendation who elects to purchase a hearing aid shall sign a receipt for the same, and the receipt shall be kept with the other papers retained by the licensed audiologist for the period provided for in Section 2539.10. Nothing in this section required to be performed by a licensed audiologist shall mean that the licensed audiologist is engaged in the diagnosis of illness or the practice of medicine or any other activity prohibited by the provisions of this code.

Section § 2539.8

Explanation

An audiologist can't sell a hearing aid to a child 16 or younger unless a physician specializing in ear, nose, and throat issues and a licensed audiologist both recommended it within the last six months. However, if it's an exact replacement of a hearing aid, this rule doesn't apply within a year.

No hearing aid shall be sold by an individual licensed as an audiologist under this chapter to a person 16 years of age or younger, unless within the preceding six months a recommendation for a hearing aid has been made by both a board-certified, or a board-eligible physician specializing in otolaryngology, and by a state licensed audiologist. A replacement of an identical hearing aid within one year shall be an exception to this requirement.