To conform with 21 C.F.R. 800.30.

 

DEPARTMENT OF HEALTH

Board of Hearing Aid Specialists

RULE NOS.:RULE TITLES:

64B6-6.002Requirements to Inform Prospective Purchasers Regarding Technologies

64B6-6.008Regular Place of Business Requirements; Advertising Requirements

64B6-6.009Posting of Prices

64B6-6.010Requirements Regarding Certain Information on the Receipt

PURPOSE AND EFFECT: To conform with 21 C.F.R. 800.30.

SUMMARY: To conform with 21 C.F.R. 800.30.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 484.044(2), 456.035(1) FS.

LAW IMPLEMENTED: 484.044(2), 484.0501(5), (7), 484.051(1), (2), (3), 484.058, 456.035 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Ashleigh Irving, Executive Director, Board of Hearing Aid Specialists, 4052 Bald Cypress Way, Bin # C08, Tallahassee, Florida 32399-3258.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64B6-6.002 Requirements to Inform Prospective Purchasers Regarding Technologies.

(1) The hearing aid specialist shall inform each prospective purchaser of a prescription hearing aid at the time of the initial examination for fitting and sale of a prescription hearing aid, any available information, including information based on personal knowledge and experience, of the telecoil, “t” coil or “t” switch technology. Said information shall include any advantages and disadvantages known to the hearing aid specialist, such as, increased access to telephones and noninvasive access to assistive listening systems required under the Americans with Disabilities Act of 1990.

(2) No Change.

Rulemaking Authority 484.044(2) FS. Law Implemented 484.044(2), 484.0501(5) FS. History–New 10-24-94, Formerly 61G9-6.0011, ___________.

64B6-6.008 Regular Place of Business Requirements; Advertising Requirements.

(1) Each licensee, upon engaging in the practice of dispensing prescription hearing aids, shall declare and establish a regular place of business, at which the licensee’s license shall be conspicuously displayed, and shall file such declaration with the Executive Director of the Board. Conspicuously displayed means easily visible to clients or prospective clients. The regular place of business shall be open to the public, and shall have posted business hours.

(2) through (4) No Change.

Rulemaking Authority 456.035(1), 484.044 FS. Law Implemented 484.058, 456.035 FS. History–New 2-28-85, Formerly 21JJ-12.01, 21JJ-12.001, Amended 8-12-87, 3-5-91, Formerly 21JJ-6.007, 61G9-6.007, Amended 3-4-08, Amended 2-20-2023, ___________.

64B6-6.009 Posting of Prices.

(1) The licensee shall display, in a conspicuous place, the availability of itemization of total purchase price of the prescription hearing aid.

(2) Notice of availability of itemization of purchase price shall be displayed in an area easily visible to the prospective client by one of the following:

(a) A minimum 6'' × 9'' sign or plaque stating in minimum 3/8'' size print or larger, in bold type:

“An itemized list of prices and services for the total purchase price of your prescription hearing aid fitting is available upon request.”

(b) For a prescription hearing aid purchased in a place other than the licensee’s regular place of business, the above statement must be given to the client at the time the client agrees to purchase a prescription hearing aid, and in ten (10) point bold face type or larger.

Rulemaking Authority 484.044 FS. Law Implemented 484.051(1), (2), 484.0501(7) FS. History–New 8-12-87, Formerly 21JJ-6.008, 61G9-6.008, Amended 11-16-04, ________________.

64B6-6.010 Requirements Regarding Certain Information on the Receipt.

(1) No Change.

(2) The receipt required by Section 484.051(3), F.S., shall contain the disclaimer “A prescription hearing aid will not restore normal hearing, nor will it prevent further hearing loss” in 10 point type or larger.

Rulemaking Authority 484.044 FS. Law Implemented 484.051(2), (3) FS. History–New 8-12-87, Amended 5-22-90, 3-5-91, Formerly 21JJ-6.009, Amended 6-26-95, Formerly 61G9-6.009, Amended 2-2-17, _____________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Hearing Aid Specialists

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Hearing Aid Specialists

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: January 27, 2023

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: February 24, 2023