BILL ANALYSIS                                                                                                                                                                                                    







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        |Hearing Date:July 13, 2009         |Bill No:AB                         |
        |                                   |1535                               |
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                      SENATE COMMITTEE ON BUSINESS, PROFESSIONS 
                               AND ECONOMIC DEVELOPMENT
                         Senator Gloria Negrete McLeod, Chair

                          Bill No:        AB 1535Author:Jones
                        As Amended:July 9, 2009  Fiscal:   Yes

        
        SUBJECT:   Audiologists:  hearing aids.
        
        SUMMARY:  Revises the definition of the practice of audiology to  
        include the selling of hearing aids, and specifies certain  
        requirements for the sale of hearing aids.  Provides that on and after  
        January 1, 2010, in addition to satisfying the licensure and  
        examination requirements, as specified, no licensed audiologists shall  
        sell hearing aids unless he or she passed an examination, approved by  
        the Speech-Language Pathology and Audiology Board (SLPAB) relating to  
        selling hearing aids.  Eliminates the Hearing Aid Dispensers Bureau  
        and consolidates its functions into the SLPAB and changes the  
        composition of the SLPAB.

        Existing law:

        1)Establishes the Speech-Language Pathologists and Audiologists  
          Licensure Act to regulate the practice of speech-language pathology  
          and audiology.  Establishes the SLPAB to license and regulate  
          speech-language pathologists and audiologists. 

        2)States that the nine-member SLPAB includes three licensed  
          speech-language pathologists, three licensed audiologists, and  three  
          public members  one of whom is a licensed physician and surgeon,  
          board certified in otolaryngology, and the remaining two public  
          members who shall be licentiates of the SLPAB, as specified.   
          Provides that the Governor appoints the physician and surgeon public  
          member and the other six licensed members, and the Senate Rules  
          Committee and the Speaker of the Assembly each appoint a public  
          member.

        3)States that the practice of audiology means the application of  





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          principles, methods, and procedures of measurement, testing,  
          appraisal, prediction, consultation, counseling, instruction related  
          to auditory, vestibular, and related functions and the modification  
          of communicative disorders involving speech, language, auditory  
          behavior or other aberrant behavior resulting from auditory  
          dysfunction; and the planning, directing, conducting, supervising,  
          or participating in programs of identification of auditory  
          disorders, hearing conservation, cerumen removal, aural  
          habilitation, and rehabilitation, including, hearing aid  
          recommendation and evaluation procedures including, but not limited  
          to, specifying amplification requirements and evaluation of the  
          results thereof, auditory training, and speech reading.

        4)Establishes within the Department of Consumer Affairs the Hearing  
          Aid Dispensers Bureau (HAD) to regulate the practice of hearing aid  
          dispensers.  Establishes the Hearing Aid Dispensers Advisory  
          Committee, consisting of seven members; three of whom shall be  
          licensed hearing aid dispensers and four of whom are public members.  
           States that only one of the licensed members may also be a licensed  
          audiologist.

        5)Defines a hearing aid dispenser as a person engaged in the fitting  
          or selling of hearing aids to an individual with impaired hearing.

        6)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.  Provides that the practice of  
          selling hearing aids does not include the act of concluding the  
          transaction by a retail clerk.

        7)Prohibits a hearing aid dispenser from conducting diagnostic hearing  
          tests when conducting tests in connection with the fitting or  
          selling of hearing aids.

        8)States that hearing aids may be sold by catalog or direct mail  
          provided that:

           a)   The seller is licensed as a hearing-aid dispenser in this  
             state.

           b)   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  





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             to the taking of an ear impression for an earmold by the seller.

           c)   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  
             consultation for specified conditions has been complied with, and  
             has conducted a direct observation of the purchaser's ear canal.

        9)Requires a hearing aid dispenser, upon consummation of a sale of a  
          hearing aid to deliver to the purchaser a written receipt containing  
          specified information.

        10)Requires that whenever specified conditions are found to exist,  
          either from observations by the licensee or on the basis of  
          information furnished by the prospective hearing aid user, a hearing  
          aid dispenser, prior to fitting or selling a hearing aid, suggest to  
          the individual in writing that it may be in his or her best interest  
          to consult with a licensed physician, as specified.

        11)Prohibits a hearing aid dispenser from selling to a person 16 years  
          of age or younger, unless a recommendation has been made by a  
          physician or audiologist, as specified. 

        12)Requires a hearing aid dispenser to keep and maintain specified  
          records for a seven-year period.

        13)Provides that a hearing aid dispenser who is the owner, manager or  
          franchisee at a location where hearing aids are fit and sold to be  
          responsible for the adequacy of the fitting or selling or any  
          hearing aid fit and sold by any hearing aid dispenser at that  
          location.

        14)Requires the HAD to prepare, approve, grade, and conduct  
          examinations of applicants for a hearing aid dispenser license.   
          Requires that each applicant take and pass a  written examination  and  
          a  practical examination  compiled at the direction of the HAD  
          covering the critical tasks involved in the fitting and selling of  
          hearing aids and the knowledge, skills, and abilities needed to  
          perform those tasks safely and competently.

        15)Specifies that hearing aids may be sold by catalog or direct mail  
          provided that certain requirements are met, including that the  
          seller is a licensed hearing aid dispenser, there is not 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.





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        16)Establishes the Newborn Hearing Screening Program implemented by  
          the Department of Health Care Services, to screen all newborns and  
          infants to identify hearing loss.

        This bill:

        1)Eliminates the HAD and consolidates its functions into the SLPAB.   
          Eliminates the HAD Fund and places those funds into the SLPAB Fund. 

        2)Revises the definition of the practice of audiology to include the  
          selling of hearing aids.

        3)Revises the composition of the SLPAB, and instead requires that the  
          six  non-public  members be made up of the following:   two  licensed  
          speech-language pathologists,  two  licensed audiologists, one of whom  
          shall be a dispensing audiologist, and  two  hearing aid dispensers.
        Retains the three public members if SLPAB, one of whom shall be a  
          physician certified in otolaryngology.

        4)Makes other clarifying and conforming changes in the Hearing Aid  
          Dispensers Licensing Law and the Speech-Language Pathologists and  
          Audiologists Licensure Act.

        This bill, similar to requirements for hearing aid dispensers:

        1)States that on and after January 1, 2010, in addition to satisfying  
          existing licensure and examination requirements, no licensed  
          audiologists shall sell hearing aids unless he or she has passed an  
           examination  , approved by the SLPAB relating to selling hearing aids.

        2)Provides that on and after January 1, 2010, a licensed audiologist,  
          with an unexpired license, to sell hearing aids pursuant to the  
          Hearing Aid Dispensers Licensing Law may continue to sell hearing  
          aids pursuant to that license until that license expires, and upon  
          expiration the licensee shall be deemed to have passed the  
          examination specified in # 1) above and may continue to sell hearing  
          aids pursuant to his or her audiology license pursuant to the  
          provisions of the Speech-Language Pathologists and Audiologists  
          Licensure Act.

        3)States that an audiologist whose license to sell hearing aids,  
          issued pursuant to the Hearing Aid Dispensers Licensing Law is  
          suspended or revoked is not authorized to sell hearing aids and  
          shall be subject to the examination requirements specified in # 1)  
          above and other provisions of the Speech-Language Pathologists and  





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          Audiologists Licensure Act.



        4)Provides that hearing aids may be sold by catalog or direct mail  
          provided that: 

           a)   The seller is licensed as an audiologist in this state.

           b)   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.

           c)   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  
             consultation for the conditions specified in item #11) below has  
             been complied with.

        5)Requires a copy of the statement referred to in item # 4) c) above,  
          to be retained by the seller for a seven-year period.

        6)Requires a licensed audiologist, 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 audiologist, containing all of the  
          following:

           a)   The date of consummation of the sale.

           b)   Specifications as to the make, serial number, and model number  
             of the hearing aid or aids sold.

           c)   The address of the principal place of business of the licensed  
             audiologist, and the address and office hours at which the  
             licensed audiologist shall be available for fitting or  
             postfitting adjustments and servicing of the hearing aid or aids  
             sold.

           d)   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.

           e)   The number of the licensed audiologist's license and the name  
             and license number of any other hearing aid dispenser, temporary  





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             licensee, or audiologist who provided any recommendation or  
             consultation regarding the purchase of the hearing aid.

           f)   The terms of any guarantee or written warranty, as specified,  
             made to the purchaser with respect to the hearing aid or hearing  
             aids.

        7)States that whenever any of the following conditions are found to  
          exist (as specified in a) to f), above), 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 his or her best interests would  
          be served if he or she would consult a licensed physician  
          specializing in diseases of the ear, or if no licensed physician is  
          available in the community, then to a duly licensed physician:

           a)   Visible congenital or traumatic deformity of the ear.

           b)   History of, or active, drainage from the ear within the  
             previous 90 days.

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

           d)   Acute or chronic dizziness.

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

           f)   Significant air-bone gap (when generally acceptable standards  
             have been established).

        8)Provides that 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.  Requires a copy of the  written  
          recommendation  to be retained by the licensed audiologist for a  
          seven-year period.  

        9)Requires that a person receiving the written recommendation who  
          elects to purchase a hearing aid to sign a  receipt  , and the receipt  
          shall be kept with the other papers retained by the licensed  
          audiologist for a seven-year period.

        10)States that nothing that is required to be performed by a licensed  





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          audiologist for the sale of a hearing aid 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 the Business and Professions Code.

        11)Prohibits the sale by of a hearing aid by an individual licensed as  
          an audiologist to a person 16 years of age or younger, unless within  
          the preceding 6 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.  
           States that a replacement of an identical hearing aid within one  
          year shall be an exception to this requirement.

        12)Requires a licensed audiologist to, upon the consummation of a sale  
          of a hearing aid, keep and maintain records in his or her office or  
          place of business at all times and each such record shall be kept  
          and maintained for a seven-year period.  These records include:

           a)   Results of test techniques as they pertain to fitting of the  
             hearing aid.

           b)   A copy of the written receipt required by item # 6) above, and  
             the written recommendation and receipt as specified in item # 8)  
             and # 9) above.

        13)Requires a licensed audiologist who is the owner, manager, or  
          franchisee at a location where hearing aids are fit or sold, to 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.

        
        FISCAL EFFECT:  According to the Assembly Appropriations Committee: 

        1)No net fiscal impact due to a fee-supported special fund reduction  
          in revenue of approximately $320,000 and an associated reduction in  
          enforcement activities connected to audiologists under current law  
          who maintain both licenses.  As a result of this bill, those with  
          two licenses will end their annual payment of the $280 HAD licensure  
          fee.  Oversight and enforcement workload for HAD will be reduced and  
          shifted to SLPAB which currently handles some hearing aid sales  
          complaints related to audiologists.

        2)The HAD is proposed for consolidation under SLPAB in the recent  
          release of the Governor's May Revision.






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        COMMENTS:
        
        1)Purpose.  According to the  Author  , this bill would allow licensed  
          audiologists to sell hearing aids under their audiology licenses,  
          rather than requiring them to also have a dispenser's (sales)  
          license administered by a second state licensing entity.  The Author  
          points out that this bill increases the accessibility of hearing  
          aids for hearing impaired patients by allowing the purchase of a  
          hearing aid directly through their audiologist, and does not affect  
          the ability of non-audiologist dispensers to sell hearing aids.   
          Consumers may go to an audiologist or a dispenser elsewhere if they  
          wish to purchase a hearing aid device.  The  California Academy of  
          Audiology  , which is the sponsor of this measure, argues that this  
          limitation dates back 
        37 years ago when hearing aid options were quite limited and thought  
          to be "unprofessional" at that time for audiologists to sell the  
          devices.  As a result, a dispenser's license was established to  
          license non-audiologists who sell the devices, and it required some  
          basic knowledge about "fitting" a hearing aid.  Over the years,  
          hearing treatment and hearing aid technology has become more  
          advanced, particularly within the pediatric population as a result  
          of the Universal Newborn Hearing Screening Programs in California  
          and other states, and many audiologists have had to get a  
          dispenser's license in order to vend the new hearing aids and fully  
          serve their patients.   Currently, 52% of the audiology licensees  
          now have a dispenser's license.  This Sponsor points out that this  
          bill removes the unnecessary dual licensing requirement for  
          audiologists to sell hearing aids.

        2)Background.  

           a)   The Practice of Audiology.  The SLPAB sets licensing standards  
             and enforces the laws governing the practices of speech-language  
             pathology and audiology.  SLPAB investigates complaints against  
             licensed and unlicensed practioners and takes disciplinary action  
             whenever appropriate.  There are roughly 1650 licensed  
             audiologists in California and approximately 50% of them are  
             licensed to dispense hearing aids.  Current law provides that to  
             be eligible for licensure as an audiologist, the applicant must  
             possess at least a master's degree in audiology from an  
             educational institution approved by the SPLAB, complete at least  
             60 units of courses related to the normal development, function,  
             and use of speech, hearing, and language; and courses that  
             provide information about, and training in, the management of  
             speech, hearing, and language disorders, and at least 24 of the  





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             60 required units be related to language resulting from hearing  
             disorders, completion of supervised clinical practice, completion  
             of no less than 36 weeks of supervised professional full-time  
             experience or 72 weeks of professional part-time experience  
             obtained under the supervision of a licensed audiologist, and  
             pass an examination approved by the SLPAB.  The examination  
             includes test items on evaluating of hearing, identifying medical  
             conditions requiring referral, fitting hearing aids, and ethics.   
             A minimum of 375 hours of supervised clinical practice is also  
             required of audiologists.  Under current law, the practice of  
             audiology does not include the selling of hearing aids, and  
             audiologists may not sell hearing aids unless they have obtained  
             a license from the HAD.   SB 821  (Committee on Business,  
             Professions and Economic Development Committee) revises the  
             educational and curriculum standards for audiologists to require  
             a doctoral level in audiology.  The doctoral level in audiology  
             provides for another full-year of classroom instruction and a  
             full-year externship to be completed under the auspices of the  
             university training program prior to the issuance of the  
             doctorate degree.

           b)   Hearing Aid Dispensers.  The HAD oversees the licensing and  
             regulation of hearing aid dispensers.  HAD informs consumers of  
             their legal rights and obligations when purchasing or returning  
             hearing aids.  It also protects consumers by maintaining  
             advertising standards as well as evaluating the competence of  
             individual dispensers.  HAD mediates complaints and enforces  
             statutory and regulatory requirements related to the practice of  
             hearing aid dispensers.  HAD licenses more than 2,200 hearing aid  
             dispensers.  Current law makes it unlawful for an individual to  
             fit or sell hearing aids, or to display a sign or to advertise to  
             be engaged in the business of fitting or selling hearing aids  
             without t a license.  To be eligible to be a hearing aids  
             dispenser, an applicant must be at least 18 years of age, and who  
             possess a high school diploma or its equivalent.  An applicant  
             must also pass written and practical examinations as prescribed  
             by the HAD.  The practical examination contains three stations,  
             and an applicant moves from one station to another in no  
             particular order.  Station A is a 30 minutes examination that  
             involves audiometric assessment or the inspection of the ear and  
             an electronic hearing assessment.  Station B is a twenty minutes  
             examination which involves taking an ear impression and  
             evaluating hearing instruments.  Finally, Station C is a 25  
             minutes examination that involves fitting and orientation and  
             post-fitting care.






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           c)   Joint Legislative Sunset Review Committee (JLSRC).  In 1998,  
             the JLSRC considered the issue of whether the scope of practice  
             of audiologist be expanded to include the practice of dispensing  
             hearing aids.  The recommendation of JLSRC staff and the  
             Department of Consumer Affairs staff was that all proposals to  
             expand the scope of practice of audiologists should be evaluated  
             on a case-by-case basis and subjected to the requirement of  
             "sunrise" review.  The JLSRC staff and DCA further recommended  
             that both the SLPAB and the Hearing Aid Dispensers Advisory  
             Committee evaluate whether there are any health and safety risks  
             posed by allowing audiologists to also sell hearing aids.   
             Subsequently, in 2006, the SLPAB submitted a report to the Joint  
             Committee on Boards, Commissions and Consumer Protection  
             (formerly JLSRC) which supported expanding the scope of practice  
             of audiologists to include the practice of dispensing of hearing  
             aids.  SLPAB indicates in this report, that for almost 30 years  
             the scope of educational training for audiologists has included  
             the selection, fitting, and dispensing of hearing aids.  In  
                                                                                addition, the application of appropriate amplification is an  
             important aspect of most other audiology courses from pediatrics  
             to aural rehabilitation in which patients are provided with  
             therapeutic techniques for overcoming the handicapping conditions  
             related to hearing loss.  The SLPAB licensing law provides that  
             audiologists are trained to select appropriate amplification and  
             evaluate patient performance with that amplification.  SLPAB  
             points out that audiologists working in the federal Veteran's  
             Administration settings (which are exempt from licensure  
             requirements) are not required to hold a hearing aid dispensers  
             license to provide hearing aid services and dispense hearing  
             instrumentation.

           d)   Other States.  According to background information provided to  
             the Committee, 30 states permit hearing aid dispensing with the  
             audiology license including Massachusetts, Alaska, Florida, and  
             Washington.  Connecticut and Texas enforce special conditions for  
             audiologists to dispense hearing aids with the audiology license  
             and New Mexico requires that audiologists obtain a separate  
             endorsement to dispense hearing aids.  On the other hand, 20  
             twenty states and the District of Columbia require audiologists  
             to hold a hearing aid dispenser licensure to dispense hearing  
             aids.

        3)DCA Legal Opinion.  An opinion by DCA counsel on the issue of  
          whether an audiologist may fit, but not sell hearing aids, without  
          being a licensed hearing aid dispenser, was submitted to the members  
          of the SLPAB on April 2, 2008.   The opinion concluded that a  





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          hearing aid dispensing license is not required as long as the  
          audiologist does not sell the devices.  In reaching this conclusion,  
          the opinion indicated that existing law codifying the practice of  
          hearing aid dispensers indicates that persons who fit or sell  
          hearing aids must be licensed as hearing aid dispensers.  However,  
          another provision points out that this requirement does not apply to  
          nor affect any licensed audiologist in conducting fitting  
          procedures, and who does not directly or indirectly engage in the  
          sale or offering for sale of hearing aids.  The opinion pointed out  
          that this means an audiologist can fit a patient with a hearing aid  
          without being licensed as a hearing aid dispenser as long as he or  
          she does not sell or offer to sell these devices.  
        
        4)Governor's Elimination, Consolidation and Reorganization Proposals.   
          The Governor's 2009-2010 Budget Act includes proposals to eliminate,  
          consolidate and reorganize boards and bureaus within the DCA.  One  
          of these proposals is the consolidation of the HAD under the SLPAB.   
          This Committee held a hearing on June 15, 2009 to consider the  
          Governor's proposals and heard testimony from the Administration,  
          the Departments, Boards and Offices that would be affected, the  
          Legislative Analyst's Office, members of the regulated professions,  
          and the public.  A report was then made to Budget Conference  
          Committee with all recommendations made by the Committee regarding  
          the Governor's Elimination, Consolidation and Reorganization  
          Proposals to the May Revision of the Budget.  The Committee  
          recommended by an 8-0 vote the following:

          Consolidate the Hearing Aid Dispensers Bureau with the  
          Speech-Language Pathology and Audiology Board.  Consideration  
          should be given to changing the composition of the Board to include  
          hearing aid dispensers.

        5)Related Legislation This Session.   SB 821  (Committee on Business,  
          Professions and Economic Development), among other provisions,  
          revises the educational and curriculum standards for licensure as an  
          audiologist to require possession of a doctorate in audiology.  SB  
          821 is pending in Assembly Business & Professions Committee.

        6)Prior Legislation.  A prior version of  AB 525  (Cohn, Chapter 48,  
          Statutes of 2003) would have allowed audiologists to sell hearing  
          aids but these provisions were amended out of the measure and the  
          bill instead required that audiologist be licensed instead of  
          certified.

        7)Arguments in Support.  The  American Academy of Audiology  (Academy),  
          an organization representing audiologists, states that audiologists  





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          are uniquely trained and educated in the evaluation, assessment,  
          diagnosis, management, treatment, and prevention of hearing and  
          balance problems.  The preparation for entry into the professions of  
          audiology allows for rigorous theoretical and clinical education and  
          training in the area of hearing aids and hearing assistive  
          technologies.  At a minimum, audiologists hold master's degrees and  
          complete clinical practicums.  The Academy also points out that it  
          has clinical practice documents that specifically address the best  
          practices in the provision of amplification (hearing aids) to both  
          children and adults.  In its support of this bill, the  California  
          Speech-Language Pathology and Audiology Board  states the change in  
          authority will result in greater access to, and overall efficiency  
          in, providing professional hearing services to the public.  SLPAB  
          states that allowing audiologists to sell hearing aids should not  
          raise concerns over competency or accuracy, as it is clear by way of  
          existing statutes, and by the education and training of audiologists  
          that they are competent to evaluate, select and fit appropriate  
          hearing aid devices for their patients.

        8)Arguments in Opposition.  (Prior to the July 9, 2009 Amendments.)   
          According to the  Hearing Healthcare Providers of California   
          (HHP/CA), this bill will benefit only those audiologists who no  
          longer have to demonstrate proficiency in fitting a hearing aid, but  
          would remove consumer protection for everyone else.  Specifically,  
          HHP/CA states that California law recognizes the potential harm to  
          consumers that could result from the improper fitting of a hearing  
          aid, and thus requires a practical examination prior to issuing a  
          license to any hearing aid dispenser, whether a physician,  
          audiologist, or hearing aid dispenser.  HHP/CA believes that passing  
          the practical examination assures consumers that the individual is  
          proficient with the skills needed to properly fit the hearing aid to  
          the consumer's satisfaction.  

        9)Suggested Amendment:  The bill as currently amended provides that  
          SLPAB has the authority to approve the examination for audiologists  
          who want to sell hearing aids.  As currently drafted, it is unclear  
          whether the current examination provided by HAD would be utilized by  
          SLPAB, or whether the SLPAB would develop a new examination to be  
          provided for audiologists.   The Committee should consider amending  
          this measure to require the SLPAB to provide the current hearing  
          dispenser's examination provided by HAD until such time the next  
          examination validation and occupational analysis is completed by the  
          Department of Consumer Affairs  .       

        
        SUPPORT AND OPPOSITION:





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         Support:  

        California Academy of Audiology (Sponsor)
        American Academy of Audiology
        California Speech-Language Pathology and Audiology Board
        California Speech-Language Hearing Association
        A number of Audiologists

         Opposition:  (Prior to the July 9, 2009 Amendments.)

        Hearing Healthcare Providers of California
        Individual Hearing Aid Dispensers


        Consultant:Rosielyn Pulmano