The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Committee on Rules
BILL: CS/SB 126
INTRODUCER: Commerce and Tourism Committee and Senator Bradley
SUBJECT: Prescription Hearing Aids
DATE: March 11, 2025
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Smith Brown HP Favorable
2. McMillan McKay CM Fav/CS
3. Smith Yeatman RC Favorable
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 126 authorizes licensed hearing aid specialists or licensed audiologists to sell and
distribute prescription hearing aids through the mail to consumers who are 18 years of age or
older.
The bill provides an effective date of July 1, 2025.
II. Present Situation:
Hearing Aids
Federal Regulations
The Food and Drug Administration (FDA) Reauthorization Act of 2017 (FDARA), s. 709,
1
directed the FDA to establish a category of over-the-counter (OTC) hearing aids through
rulemaking and set forth various requirements for OTC hearing aids, including defining general
controls for reasonable assurance of safety and effectiveness, as well as Federal preemption
provisions.
1
21 U.S.C. 301, Food and Drug Administration Reauthorization Act of 1917, s. 709, Regulation of Over-The-Counter
Hearing Aids, available at https://www.congress.gov/115/plaws/publ52/PLAW-115publ52.pdf (last visited Feb. 28, 2025).
REVISED: BILL: CS/SB 126 Page 2
On August 17, 2022, the FDA finalized a rule revising 21 C.F.R. 800,
2
801,
3
and 874.
4
The
FDA’s new rule establishes a new category for OTC hearing aids. An OTC hearing aid is an air-
conduction hearing aid that does not require implantation or other surgical intervention and is
intended for use by a person aged 18 or older to compensate for perceived mild to moderate
hearing impairment. The device, through tools, tests, or software, allows the user to control the
hearing aid and customize it to the user’s hearing needs. The device may use wireless technology
or may include tests for self-assessment of hearing loss.
The device is available OTC, without the supervision, prescription, or other order, involvement,
or intervention of a licensed person, to consumers through in-person transactions, by mail, or
online, provided that the device satisfies the requirements for consumers with “perceived mild to
moderate hearing impairment” who wish to buy lower cost hearing aids not bundled with
professional services and not requiring professional advice, fitting, adjustment, or maintenance.
The rule became effective on October 16, 2022.
5
The FDA rule includes provisions for simplified labeling, output limits, maximum insertion
depth, and conditions for sale and distribution for both OTC and prescription hearing aids. The
rule prohibits states from requiring the order, involvement, or intervention of a licensed person
for consumers to access OTC hearing aids; a licensed person may service, market, sell, dispense,
provide customer support for, or distribute OTC hearing aids.
Florida Regulations
In Florida, there are currently 1,289 licensed hearing aid specialists, and 1,654 licensed
audiologists.
6
In 2023, Florida’s practice acts for hearing aid specialists and audiologists were
amended to distinguish between prescription hearing aids and OTC hearing aids to conform to
the new FDA rules.
7
Under Florida law, prescription hearing aids are dispensed by hearing aid
specialists and audiologists who are subject to the Department of Health (DOH) regulation under
the Board of Hearing Aid Specialist (BHAS) and Board of Speech-Language Pathology and
Audiology (BSLPA).
8
Selling or distributing prescription hearing aids through the mail to the
ultimate consumer is unlawful and is punishable as a misdemeanor of the second degree.
9
Scope of Practice
Florida law defines the scope of practice for hearing aid specialists and audiologists and specifies
the procedures which each health care practitioner is authorized to perform. Both hearing aid
2
21 CFR 800.30, available at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-800#800.30 (last visited
Mar. 4, 2025).
3
21 CFR 801.60 - 63, available at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-C (last
visited Mar. 4, 2025).
4
21 CFR 874.5300 available at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-874/subpart-F/section-
874.5300 (last visited Mar. 4, 2025).
5
21 CFR 800.30, available at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-800#800.30 (last visited Mar.
4, 2025).
6
Florida Department of Health, Division of Medical Quality Assurance, Annual Report and Long Range Plan, 2023 - 2024,
available at https://mqawebteam.com/annualreports/2324/ (last visited Mar. 4, 2025).
7
Laws of Fla. 2023-71.
8
See Part II, ch. 484, and Part I, ch. 468, F.S., respectively.
9
Sections 468.1265 and 484.054, F.S. BILL: CS/SB 126 Page 3
specialists and audiologists may provide services through telehealth within this state.
10
Out-of-
state hearing aid specialists and audiologists may register to provide services through telehealth
to patients located in this state.
11
Hearing Aid Specialists
Under s. 484.041, F.S., hearing aid specialists may dispense prescription hearing aids.
Dispensing prescription hearing aids includes conducting and interpreting hearing tests for
purposes of selecting suitable hearing aids, making earmolds or ear impressions for the fitting of
hearing aids, and providing appropriate counseling regarding a suitable hearing aid device. This
also includes all acts pertaining to the selling, renting, leasing, pricing, delivery, and warranty of
hearing aids.
12
Hearing aid specialists are licensed and regulated by the BHAS.
13
Licensure for a hearing aid
specialist is in accordance with s. 484.045, F.S., and includes the following requirements:
• Graduation of an accredited high school or its equivalent;
• Meeting one of the qualifying methods:
o Completing a Florida sponsored training program;
o Having a valid, current license as a hearing aid specialist or its equivalent from another
state and has been actively practicing
14
in such capacity for at least 12 months; or
o Is currently certified by the National Board for Certification in Hearing Instrument
Sciences (NBC-HIS) and has been actively practicing for at least 12 months.
• Has successfully completed:
o International Licensing Examination (ILE); or
o Active certification from the National Board for Certification in Hearing Instrument
Sciences (NBC-HIS).
• Completion of a two-hour course relating to Florida laws and rules taught by an instructor
approved by the BHAS.
Effective July 1, 2025, an applicant for licensure must also submit to a background screening test
in accordance with s. 456.0135, F.S.
Audiologists
The practice of audiology includes the application of principles, methods, and procedures for the
prevention, identification, evaluation, consultation, habilitation, rehabilitation, instruction,
treatment, and research, relative to hearing and the disorders of hearing, and to related language
and speech disorders.
15
Licensed audiologists may offer, render, plan, direct, conduct, consult, or
supervise services to individuals or groups of individuals who have or are suspected of having
disorders of hearing, including prevention, identification, evaluation, treatment, consultation,
10
Section 456.47, F.S.
11
Id.
12
Section 484.041(3)(a), F.S.
13
Section 484.042, F.S.
14
See Fla. Admin. Code R. 64B6-2.002 (2025), which defines “actively practicing” as dispensing hearing aids directly to
clients for at least 12 months, as shown by at least two sales receipts per month for at least 12 months, each receipt bearing
the applicant’s signature and address of place(s) of business.
15
Section 468.1125(6)(a), F.S. BILL: CS/SB 126 Page 4
habilitation, rehabilitation, instruction, and research.
16
This includes the fitting and dispensing of
hearing aids. They may also provide the following:
• Participate in hearing conservation, evaluation of noise environment, and noise control;
• Conduct and interpret tests of vestibular function and nystagmus, electrophysiologic
auditory-evoked potentials, central auditory function, and calibration of measurement
equipment used for such purposes;
• Habilitate and rehabilitate, including, but not limited to, hearing aid evaluation, prescription,
preparation, fitting and dispensing, assistive listening device selection and orientation,
auditory training, aural habilitation, aural rehabilitation, speech conservation, and
speechreading;
• Fabricate earmolds;
• Evaluate tinnitus; and
• Conduct speech and language screening, limited to a pass-fail determination for identifying
individuals with disorders of communication.
17
Audiologists are licensed and regulated by the BSLPA.
18
Licensure for audiologists includes,
among other requirements, the following:
• Submission of an application and all required fees.
• A doctoral degree with a major emphasis in audiology and:
o Applicants who have earned a doctoral degree from an approved program before
January 1, 2008, must complete 60 semester hours, 24 of which must be in audiology.
19
o Applicants who earned a doctoral degree from an approved program after
January 1, 2008, must complete 75 semester hours.
o 300 clock hours of supervised experience (clinical practicum) with at least 200 hours in
the area of audiology.
• Eleven months of supervised clinical experience. This requirement may be met if the
applicant holds a doctoral degree, meets the requirements of s. 468.1155, F.S., and can
demonstrate one year of clinical work experience within the doctoral program.
• Applicants for licensure as an audiologist with a master’s degree conferred before January 1,
2008, must document that, prior to licensure, the applicant completed one year of clinical
work experience.
• Passing the licensure examination no more than three years prior to the date of the
application.
20
Effective July 1, 2025, an applicant for licensure must also submit to a background screening test
in accordance with s. 456.0135, F.S.
16
Section 468.1125(6)(b), F.S.
17
Id.
18
Section 468.1135, F.S.
19
Section 468.1155, F.S.
20
Section 468.1185, F.S. and Fla. Admin. Code R. 64B20-2.005 (2022) The BSDPA has designated the Educational Testing
Services Praxis Series Examination in Speech-Language Pathology or Audiology as the licensure examination. BILL: CS/SB 126 Page 5
Minimal Procedures and Equipment
21
Florida law requires hearing aid specialists, and audiologists only when indicated, to perform all
of the following procedures to be used in the fitting and selling of prescription hearing aids:
• Pure tone audiometric testing by air and bone to determine the type and degree of hearing
deficiency.
• Effective masking.
• Appropriate testing to determine speech reception thresholds, speech discrimination scores,
the most comfortable listening levels, uncomfortable loudness levels, and the selection of the
best fitting arrangement for maximum hearing aid benefit.
A wide range audiometer that meets the specifications of the American National Standards
Institute for diagnostic audiometers, and a speech audiometer or a master hearing aid must be
used by hearing aid specialists, and audiologists only when indicated, in the fitting and selling of
prescription hearing aids.
A hearing aid specialist must make a final fitting ensuring physical and operational comfort of
the prescription hearing aid. An audiologist must make such a final fitting only when indicated.
Each audiometric test must be made in a testing room that has been certified by the DOH and
meets certain requirements established in statute and rule. However, this requirement may be
waived by a client who has been provided written notice of the benefits and advantages of having
the test conducted in a certified testing room.
III. Effect of Proposed Changes:
The bill provides that prescription hearing aids may be distributed through the mail to a patient
who is 18 years of age or older before the patient's scheduled telehealth appointment with a
licensed audiologist. The prescription hearing aids may not be activated unless the audiologist
has prescribed them. If prescribed, the audiologist must conduct a fitting during the telehealth
appointment or a subsequent appointment to ensure the physical and operational comfort of the
prescription hearing aids.
The bill provides that prescription hearing aids may be distributed through the mail to a patient
who is 18 years of age or older before the patient's scheduled telehealth appointment with a
licensed hearing aid specialist. The prescription hearing aids must not be activated unless the
hearing aid specialist has determined that the patient should be fitted for prescription hearing
aids. If that determination is made, the hearing aid specialist must conduct a fitting during the
telehealth appointment or a subsequent appointment to ensure the physical and operational
comfort of the prescription hearing aids.
The bill establishes that any person who sells or distributes prescription hearing aids through the
mail to the ultimate consumer commits a misdemeanor of the second degree.
The bill takes effect July 1, 2025.
21
Sections 468.1225 and 484.0501, F.S. See also Fla. Admin. Code R. 64B6-6, 64B20-8, and 64B20-9. BILL: CS/SB 126 Page 6
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
None Identified.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
None.
C. Government Sector Impact:
To implement the bill, the Department of Health would need to develop a communication
plan to ensure compliance and operational readiness. The department anticipates that this
would include updating websites and the Artificial Intelligence chatbot, notifying
stakeholder groups, and communicating the statutory changes to staff through training.
22
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
22
Department of Health, Senate Bill 126 Legislative Analysis (Feb. 11, 2025) (on file with the Senate Committee on Health
Policy). BILL: CS/SB 126 Page 7
VIII. Statutes Affected:
This bill substantially amends sections 468.1265 and 484.054 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Substantial Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
CS by Commerce and Tourism on March 3, 2024:
The committee substitute provides that prescription hearing aids may be distributed
through the mail to a patient who is 18 years of age or older before the patient's scheduled
telehealth appointment with a licensed audiologist. The prescription hearing aids may not
be activated unless the audiologist has prescribed them. If prescribed, the audiologist
must conduct a fitting during the telehealth appointment or a subsequent appointment to
ensure the physical and operational comfort of the prescription hearing aids.
The committee substitute also provides that prescription hearing aids may be distributed
through the mail to a patient who is 18 years of age or older before the patient's scheduled
telehealth appointment with a licensed hearing aid specialist. The prescription hearing
aids must not be activated unless the hearing aid specialist has determined that the patient
should be fitted for prescription hearing aids. If that determination is made, the hearing
aid specialist must conduct a fitting during the telehealth appointment or a subsequent
appointment to ensure the physical and operational comfort of the prescription hearing
aids.
Except in the above instances, any person who sells or distributes prescription hearing
aids through the mail to the ultimate consumer commits a misdemeanor of the second
degree.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.