Date of Hearing: May 16, 2019

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

ABPCA Bill Id:AB 780

Author:(Brough) – As Amended Ver:April 25, 2019

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill authorizes hearing air dispensers to perform tympanometry and cerumen management, as specified, and establishes an apprenticeship pathway to licensure.

FISCAL EFFECT:

1. $120,000 ongoing in staffing costs to the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board (board) to implement the apprentice program and issue advance practice certificates (Speech-Language Pathology and Audiology and Hearing Aid Dispensers Fund).
2. $120,000 one-time to the board for information technology upgrades to accommodate the new certification types and enforcement categories (Speech-Language Pathology and Audiology and Hearing Aid Dispensers Fund).

COMMENTS:

1. Purpose. This bill seeks to expand the scope of practice of hearing air dispensers to allow them to perform two procedures. It also codifies a federally approved apprenticeship program that provides an alternate pathway to licensure.
2. Background. The board is charged with the regulation of the practices of speech-language pathology, audiology, and hearing aid dispensing. Licensed audiologists and hearing aid dispensers are permitted to dispense hearing aids if they meet the appropriate requirements. In order to become a hearing air dispenser, an applicant must be 18 years of age, have a high school degree and pass a practical examination developed by the board.

Cerumen management is removal of earwax. According to the American Speech-Language-Hearing Association (ASHA), the professional organization representing audiologists and speech-language pathologists, most state scope-of-practice laws describe cerumen management as a function performed by audiologists.

Tympanometry provides practitioners quantitative information about the presence of fluid in the middle ear, mobility of the middle ear system and ear canal volume. Fluid in the middle ear space prevents the eardrum from moving and transmitting sound properly; thus, a hearing aid may not be indicated if there is fluid in the ear. Screening tympanometers are generally small handheld devices that provide a digital readout of the test results. This bill allows the use of such a device “for the sole purposes of screening related to fitting and maintaining hearing aids and referring a patient to a physician and surgeon specializing in otolaryngology.”

According to the board, there are currently three pathways to licensure: passing the written and practical exams, seeking training and supervision under an existing hearing air dispenser then passing the exams, or, if an applicant has a license from another state, applying for a temporary license then passing the California exams. This bill would create another training pathway to licensure with different standards.

1. Support. This bill is sponsored by Hearing Healthcare Providers/California, who state current licensure requirements are onerous for licensees to abide by and fall short on practical training standards that lead to better patient care. They also note existing law is not explicit in granting a hearing aid dispenser the authority to perform tympanometry, resulting in potentially overlooked health problems.
2. Opposition. The Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board opposes this bill, stating tympanometry is a diagnostic procedure and not required nor indicated for the fitting of hearing aids. The board notes a potential for consumer harm with tympanometry, including pain and discomfort, exposure to high levels of sound, and the possibility of eardrum rupture, indicating there is no mechanism for guaranteeing consumer protection when tympanometry is provided by an individual who lacks appropriate education and training. The board also notes apprentice hearing aid dispenser license will increase costs for the board without creating an incentive for individuals to choose this pathway to licensure. The Academy of Doctors of Audiology, the California Academy of Audiology and the California Speech-Language-Hearing Association also oppose.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: April 23, 2019

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Evan Low, Chair

ABPCA Bill Id:AB 780

Author:(Brough) – As Amended Ver:April 22, 2019

SUBJECT: Hearing aid dispensers: apprentice license.

SUMMARY: Authorizes a Hearing Aid Dispenser (HAD) to perform tympanometry and cerumen management, as specified, and establishes an apprenticeship pathway to licensure.

EXISTING LAW:

1. Provides for the regulation and licensure of the dispensing of hearing aids by the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board (Business and Professions Code (BPC) §§ 2538.10-2538.57)
2. Defines the “practice of fitting or selling hearing aids” as those practices used for the purpose of selection and adaptation of hearing aids, including direct observation of the ear, testing of hearing in connection with the fitting and selling of hearing aids, taking of ear mold impressions, fitting or sale of hearing aids, and any necessary postfitting counseling. (BPC § 2538.11(a))
3. Prohibits a hearing aid dispenser from conducting diagnostic hearing tests when conducting tests in connection with the practice of fitting or selling hearing aids. (BPC § 2538.11(b))

THIS BILL:

1. Expands the practice of fitting or selling hearing aids to include cerumen management and tympanometry for patients 18 years of age and older.
2. Authorizes a licensed hearing aid dispenser to sit for an examination assessing techniques and patient safety measures in cerumen management or tympanometry.
3. Requires the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board to apply courses in cerumen management and tympanometry to the continuing education requirements.
4. Requires the administration of cerumen management to occur under supervision of a physician and surgeon.
5. Establishes an apprentice hearing aid dispenser license.
6. Establishes the duration of the apprenticeship as 18 months and establishes requirements for an apprentice to sit for the practical examination required for licensure as a hearing aid dispenser, including completion of a specified course and at least 12 months of directly supervised practicum training.
7. Requires the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board to establish a list of approved courses for an apprentice hearing aid dispenser training program.

FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

Purpose. This bill is sponsored by Hearing Healthcare Providers/California. According to the author, “The California Department of Aging projects that the elderly population will grow more than twice as fast as the general population. This rapidly growing population also suffers from hearing loss at a much higher rate than other demographics – many of them ultimately decide to purchase hearing aids from California licensed hearing aid dispensers. An apprenticeship program for people interesting in becoming a licensed hearing aid dispenser that includes significant supervision and on the job training would allow for improved training standards as a pathway to licensure, which will lead to increased access for the hearing impaired and ensure greater patient care. Making these changes in law will ensure that patients who get fitted for and purchase their hearing aids through a licensed dispenser are receiving the best care when the professional is trained to highest level of industry standards and can perform a full array of services, including cerumen management and tympanometry that are commonly performed by hearing aid dispensers across the country.”

Background. Hearing aid dispensers are licensed practitioners who fit and sell hearing aids. Hearing aids are wearable devices designed for aiding or compensating for impaired hearing. In order to become a HAD, an applicant must be 18 years of age, have a high school degree, and pass a practical examination developed by the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board.

The Board is a licensing entity within the Department of Consumer Affairs (DCA). The Board’s purpose is to protect California consumers by promoting standards and enforcing the laws and regulations that ensure the qualifications and competence of providers of speech-language pathology, audiology and hearing aid dispensing services. According to the 2018 DCA Annual Report, the Board had 1,266 licensed Hearing Aid Dispensers out of a total of 29,620 licensees, which include SLPs, Audiologists, and various trainees and aids.

Hearing Tests. Prior to fitting a hearing aid, an HAD is authorized to use an audiometer to test measure hearing acuity. The purpose of the hearing test is to prevent the improper dispensing of a hearing aid. This bill would additionally authorize an HAD to perform tympanometry as an additional layer of screening. According to the sponsor, tympanometry can indicate other hearing problems that can then be more accurately addressed when fitting and calibration of a device.

Cerumen Management. This bill would also authorize an HAD to perform cerumen management. According to the sponsors, cerumen management involves several methods of removing ear wax from the inner ear. People who wear hearing aids are prone to having additional cerumen in their ears, making removal more necessary and the maintenance of their hearing aids more difficult. Currently, HADs must refer patients out of our offices and to a physician and surgeon or audiologist in order to remove excess ear wax, and according to the sponsor, sending patients out of the office for this service creates a disruption in care and results in extra costs to the patient.

Apprenticeship Program. According to the sponsor, this bill codifies a federally-approved apprenticeship program that provides a rigorous framework for entrants into the profession that would be another pathway to licensure. While the program is optional, it would allow for more people to enter the profession through traineeships and on the job supervision by licensed dispensers. Applicants would still have to take the written and practical exams.

Prior Related Legislation. SB 198 (Galgiani), which failed passage in the Senate Business, Professions, and Economic Development Committee in 2017, would have included cerumen management and tympanometry for patients 18 years of age and older in the practice of fitting or selling hearing aids, as specified.

ARGUMENTS IN SUPPORT:

According to the Hearing Healthcare Providers/California, “California offers no formal educational programs to become a licensed hearing aid dispenser. The only requirements for licensure are possession of a high school diploma and passing a written and practical exam. However, many people who enter the profession go through traineeships, on the job supervision by licensed dispensers. The Board recently approved regulations that, while they improve upon the existing framework for supervision, they are onerous for licensees to abide by, and fall short on practical training standards that will lead to better patient care. The U.S. Department of Labor has approved an apprenticeship program, developed by HHP’s national affiliate, that provides a rigorous framework for entrants into the profession that should be another pathway to licensure. Applicants would still have to take the written and practical exams.”

“Tympanometry can indicate other hearing problems that can then be more accurately addressed when fitting and calibration of a device. However, existing law is not explicit in granting a hearing aid dispenser the authority to perform tympanometry, resulting in potentially overlooked health problems.”

“Adding an industry-informed apprenticeship program with increased supervisory standards and educational content will better train new hearing aid dispensers. Allowing qualified and properly trained hearing aid dispensers to perform tympanometry will better serve patients in getting the treatment they need, as well as better-calibrated devices for everyday use.”

ARGUMENTS IN OPPOSITION:

According to the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board, “This bill would allow hearing aid dispensers to perform tympanometry, which is a diagnostic procedure, and not required nor indicated for the fitting of hearing aids. Hearing aid dispensers are licensed solely to fit and sell hearing aids. The requirements for fitting and selling include: being 18 years of age, possessing a high school diploma, and passing the state's hearing aid dispensing written and practical examinations, which are designed to ensure a minimum level of competence in fitting hearing aids. There is a potential for consumer harm with tympanometry, including pain/discomfort, exposure to high levels of sound, and the possibility of eardrum rupture. There is no mechanism for guaranteeing consumer protection when provided by an individual who lacks the appropriate education and training.”

“This bill would also create a new license type for an apprentice hearing aid dispenser. While laudable that this bill seeks to offer additional education opportunities for individuals interested in entering the profession, as currently written, the apprentice hearing aid dispenser license will increase costs for the Board without creating an incentive for individuals to choose this pathway to licensure.”

IMPLEMENTATION ISSUES:

Duplicative Apprenticeship Pathways. This bill establishes an apprenticeship pathway as an alternative to licensure. However, the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board has already developed a similar program. As a result, there are now three optional methods for licensure. However, because the apprenticeship and supervision pathways are not required for licensure, the author may wish to consider consolidating the various pathways if this bill passes this Committee.

AMENDMENTS:

1. Limitations on Cerumen Management and Tympanometry. The baseline education for HADs does not include training in tympanometry or cerumen management. Therefore, the author may wish to amend the bill to limit the scope of the procedures as follows:

Page 4, line 31, through page 5:

2538.11. (a) (1) “Practice of fitting or selling hearing aids,” as used in this article, means those practices used for the purpose of selection and adaptation of hearing aids, including direct observation of the ear, testing of hearing in connection with the fitting and selling of hearing aids, taking of ear mold impressions, fitting or sale of hearing aids, and any necessary postfitting counseling. The practice of fitting or selling hearing aids may include cerumen management or tympanometry for patients 18 years of age and older.

(2)  For the purposes of this section, “cerumen management” means the removal of cerumen no further than the cartilaginous outer third of the ear canal for the sole purpose of inspecting the ears, making impressions, or fitting and maintaining hearing aids.

(3) For the purposes of this section, “tympanometry” means the administration of the test for use of a screening tympanometer for the sole purposes of screening related to fitting and maintaining hearing aids or and referring a patient to a specialist physician and surgeon. specializing in otolaryngology.

1. Tympanometer Definition. Because tympanometry is normally a diagnostic tool, the author may wish to amend the bill to limit the use of a tympanometer to those with screening functions only:

Page 5, after line 16, insert:

(4) For purposes of this section, “screening tympanometer” means a device that has been approved by the federal Food and Drug Administration for auditory impedance testing and meets the following criteria:

(A) Is a handheld device with a digital screen that utilizes a probe.

(B) Notifies the user of issues that will impact the accuracy of the measurement, including, but not limited to, whether the probe is in the ear and has formed a seal or there is a block or leak.

(C) Performs an automatic tympanogram measurement on a single ear.

(D) Displays results on the digital screen or printout.

(E) Includes screening functions for each result that do not require calculation or discretionary intervention by the user, including, but not limited to, a pass/fail indicator or a box indicating a normative range where the peak of the tympanogram is expected under normal conditions.

1. Additional Screening. Because concerns have been raised about the risks of cerumen management and tympanometry, the author may wish to amend the bill to require additional screening pursuant to federal Food and Drug Administration Guidelines relating to HAD safety:

Page 5, line 17, insert:

(d) A licensed hearing aid dispenser shall advise a prospective hearing aid user to consult promptly with a physician and surgeon who specializes in otolaryngology and shall not test a prospective user or dispense, except upon referral by a physician and surgeon, a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions:

(1) Visible congenital or traumatic deformity of the ear.

(2) History of active drainage from the ear within the previous 90 days.

(3) History of sudden or rapidly progressive hearing loss within the previous 90 days.

(4) Acute or chronic dizziness.

(5) Unilateral hearing loss of sudden or recent onset within the previous 90 days.

(6) Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.

(7) Except as provided under subdivision (e), visible evidence of significant cerumen accumulation or a foreign body in the ear canal.

(8) Pain or discomfort in the ear.

1. Advanced Practice Certificate. Because there are no educational requirements for HADs besides a practical exam, the author may wish to amend the bill to require additional training and an advanced practice certificate in order to practice tympanometry and cerumen management:

Page 5, lines 20-27:

(e) (1) A licensed hearing aid dispenser who has passed the examinations described in Section 2538.25 is eligible to sit for board-approved examinations assessing techniques and patient safety measures in cerumen management or tympanometry. The examinations approved by the board shall be sufficient to demonstrate proficiency in cerumen management or tympanometry and the knowledge, skills, and abilities needed to perform these techniques safely. The board shall issue an advanced practice certificate to a licensed hearing aid dispenser who meets the following requirements:

(A) At least two years of practice as a licensed hearing aid dispenser.

(B) Not subject to discipline or other enforcement action by the board.

(C) Completion of the International Hearing Society’s Distance Learning for Professionals in Hearing Health Sciences course or another comparable course or certificate program approved by the board.

(D) Attests under penalty of perjury, along with a supervising mentor or trainer licensed under this division and competent to provide cerumen management, that the licensed applicant has received direct supervised training from the supervising licensee sufficient to ensure the safe administration of cerumen management.

1. Tympanometry Protocols Because HADs are not currently trained in the use of tympanometry and they will not be authorized to diagnose using a tympanometer, the author may wish to clarify that it is only to be used for purposes of screening, that it is only to be used in conjunction with other tests, and require additional consumer disclosures to avoid consumer confusion:

Page 5, after line 27:

(2)  Notwithstanding any other law, the board shall apply board-approved courses in tympanometry to the continuing education requirement described in Section 2538.18. In order to be board approved, a course shall cover the knowledge, skills, and abilities needed to perform tympanometry safely. In addition to the practices specified under subdivision (a), a licensed hearing aid dispenser with an advanced practice certificate issued by the board may perform cerumen management and tympanometry screening for patients 18 years of age and older.

(3) Tympanometry by a licensed hearing aid dispenser with an advanced practice certificate shall only be performed as follows:

(A) The licensed hearing aid dispenser obtains specific informed consent from the prospective hearing aid user to perform tympanometry for screening purposes only and advises the prospective user that the licensee is not a physician and surgeon, licensed audiologist, or any other licensee authorized to diagnose under state law.

(B) The tympanometry is only performed in conjunction with otoscopy and pure-tone and speech audiometry. If any test detects an abnormality, the licensee shall refer the prospective hearing aid user to a physician and surgeon. Tympanometry shall not be used to invalidate the results of another test with the intent of improperly dispensing a hearing aid.

(C) The licensed hearing aid dispenser has a referral and medical contingency agreement with a physician and surgeon who specializes in otolaryngology is readily available.

1. Cerumen Management Protocols. Because HADs are not currently trained in cerumen management, the author may wish to limit the types of tools that may be used, may wish to specify infection control guidelines, may wish to require liability insurance, may wish to require referral agreements, and may wish to clarify that violations constitute grounds for revocation:

Page 5, after line 33:

(4) The administration of cerumen management by a licensed hearing aid dispenser with an advanced practice certificate shall occur under physician and surgeon supervision. Physician and surgeon supervision shall not be construed to require the physical presence of the physician and surgeon, but does include (A) collaboration on the development of the standardized procedure, (B) approval of the standardized procedure, and (C) availability by telephonic contact at the time of patient examination by the licensed hearing aid dispenser. meet the following conditions:

(A) The cerumen management is performed using a cotton swab or plastic curette. A suction or irrigation device approved by the federal Food and Drug Administration for cerumen removal may only be used if the prospective hearing aid user does not have diabetes, a perforated tympanic membrane, tube in the tympanic membrane, or a weakened immune system.

(B) The licensee follows the federal Centers for Disease Control and Prevention guidelines for infection control.

(C) The licensee carries liability insurance covering cerumen management.

(D) The licensee obtains specific informed consent from the prospective hearing aid user to perform cerumen management and advises the prospective user of the risks of cerumen management, as outlined under paragraph (4).

(4E) A The licensed hearing aid dispenser has a referral and medical contingency agreement with a physician and surgeon specializing in otolaryngology who is readily available shall and the licensee immediately refers a patient prospective hearing aid user to an appropriate the physician or surgeon if the patient prospective hearing aid user demonstrates any trauma, including tears, bleeding, or other pathology of the ear discovered in the process of cerumen management.

(5) A physician and surgeon may not simultaneously supervise more than two hearing aid dispensers for purposes of cerumen management.Violation of any provision of this chapter shall constitute grounds for revocation of an advanced practice certificate.

1. Apprentice Sponsor Qualifications. Because there is currently no training for HADs, the author may wish to amend the bill to require sponsors of the new apprentices to have an advanced certificate, not be subject to discipline, and be limited to supervising one apprentice at a time:

Page 6, lines 8-14:

(b) An apprentice sponsor is a licensed hearing aid dispenser who has held a valid hearing aid dispenser’s license issued by the board for at least three years, is not subject to discipline or other enforcement action by the board, is the holder of an advanced practice certificate under Section 2538.11, and has agreed to act as an apprentice sponsor to the applicant. An apprentice sponsor shall be responsible for the day-to-day supervision of the apprentice, and shall be responsible for services provided to a client by the apprentice hearing aid dispenser.

Page 7, last two lines:

(j) An apprentice sponsor shall not supervise more than three one apprentices at one time. apprentice at one time, except as authorized by the board.

REGISTERED SUPPORT:

Hearing Healthcare Providers/California (sponsor)

REGISTERED OPPOSITION:

Academy of Doctors of Audiology

California Academy of Audiology

California Speech-Language-Hearing Association

Speech-Language Pathology & Audiology & Hearing Aid Dispensers Board

Numerous individual businesses, audiology faculty, audiologists, and audiology students

Two otolaryngologists

Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301