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

 

DEPARTMENT OF HEALTH

Board of Hearing Aid Specialists

RULE NOS.:RULE TITLES:

64B6-2.002Definitions

64B6-2.005Reexamination

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, 484.0445, 484.045, 456.017(2) FS.

LAW IMPLEMENTED: 484.0445, 484.045 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:

 

64B6-2.002 Definitions.

For the purpose of this chapter the following definitions apply:

(1) Prescription Hearing Aid means a hearing aid or amplifying sound device that is not an Over-the-Counter Hearing Aid (OTC) as defined in Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids, 21 CFR Section 800.30 (2022), which is specifically incorporated by reference herein, available at http://www.flrules.org/Gateway/reference.asp?No=Ref- .  Hearing aids intended for people younger than 18 years of age are prescription hearing aids.

(2) Over-the-Counter Hearing Aid (OTC) means certain air-conduction hearing aids regulated by the Food and Drug Administration (FDA), in accordance with 21 CFR Section 800.30 (2022), intended for people 18 years of age and older who have perceived mild to moderate hearing loss.

(31) “Actively practicing” means dispensing prescription hearing aids directly to clients at least twelve (12) months, as shown by at least two sales receipts per month for at least twelve (12) months, each receipt bearing the applicant’s signature and address of place(s) of business.

(2) through (4) renumbered as  (4) through (6) No Change.

Rulemaking Authority 484.044, 484.0445, 484.045 FS. Law Implemented 484.0445, 484.045 FS. History–New 12-21-86, Amended 5-22-90, Formerly 21JJ-2.002, 61G9-2.002, Amended 10-8-02, 3-2-22, __________________.

 

64B6-2.005 Reexamination.

(1) No Change.

(2) No person may further perform any prescription hearing aid dispensing services if she or he fails to either sit for or pass the next available examination for which he or she qualifies, unless he or she is eligible to continue in the training program pursuant to subsection 64B6-8.003(6), F.A.C.

Rulemaking Authority 456.017(2), 484.044, 484.0445 FS. Law Implemented 484.0445, 484.045 FS. History–New 12-21-86, Amended 2-16-89, 5-22-90, Formerly 21JJ-2.006, 61G9-2.006, Amended 6-6-02, 4-23-09, _____________.

 

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 22, 2023