# October 8, 2008

Michael J. Astrue

Commissioner of Social Security

P.O. Box 17703

Baltimore, MD 21235-7703

**RE: RIN 0960-AG20 -- International Hearing Society Request to Include
Hearing Aid Specialists as Providers of Audiometric Testing (Docket No.
SSA-2008-0016)**

Dear Commissioner Astrue:

The International Hearing Society (IHS), founded in 1951, represents the
nation's 10,000 hearing aid specialists. IHS appreciates the opportunity
to comment on the Social Security Administration's Notice of Proposed
Rulemaking that seeks to revise the medical criteria for evaluating
hearing loss (73 Fed. Reg. 47103, August 13, 2008).

Hearing aid specialists are health care professionals licensed or
registered by every state specifically to provide services for the
hearing impaired and their families, including audiometric testing of
hearing, selecting and fitting of hearing aids, as well as ongoing
follow-up care and counseling. IHS requests the inclusion of hearing aid
specialists as providers of the audiometric testing required by the
Social Security Administration for purposes of evaluating adult hearing
loss.

Inclusion of hearing aid specialists as providers of audiometric testing
is warranted because the tests required by the Social Security
Administration are all routinely administered by hearing aid
specialists. These tests include pure tone air conduction and bone
conduction testing, speech reception threshold (SRT) testing, and word
recognition/speech discrimination testing.

As you will see from the attached Practice Profile of the hearing aid
specialist, the range of services provided by hearing aid specialists
includes, but is not limited to: eliciting patient case histories;
administering otoscopy (examination of the ear using a medical device
known as an otoscope, which allows the provider to view the interior of
the ear); administering and interpreting tests of human hearing;
determining candidacy for hearing instruments and assistive devices;
referring as appropriate for cochlear implant evaluation or other
clinical, rehabilitative, or medical interventions; prescribing,
selecting and fitting appropriate hearing instruments and assistive
devices; assessing hearing instrument efficacy utilizing appropriate
fitting verification methodology; taking ear impressions and preparing,
designing, and modifying ear molds; and providing counseling and aural
rehabilitative services.

Hearing aid specialists must pass a state examination and meet
appropriate training/education requirements to be licensed.
Additionally, hearing aid specialists maintain their professional
competency through continued education. The International Institute for
Hearing Instruments Studies (IIHIS) is responsible for IHS's education
materials. IIHIS accredits educational programs for continuing education
credit and is the leading publisher of industry-related textbooks. IIHIS
provides the written licensing examination for 38 states and three
Canadian provinces.

Founded in 1981, the National Board for Certification in Hearing
Instrument Sciences was created to establish a standardized test for
measuring the competency of hearing health professionals. It is the only
national standard that measures competency in the testing, selection and
fitting of hearing instruments. In addition, NBC-HIS is the only board
certification program in the hearing health care sector accredited by
the National Commission for Certifying Agencies.

The designation BC-HIS (Board Certified in Hearing Instrument Sciences)
distinguishes the outstanding skills and professional expertise needed
for completion of the rigorous National Competency Exam (NCE)
administered by NBC-HIS. The NCE is designed to test the knowledge and
skill levels needed to be a successful hearing instrument practitioner.
Candidates for the National Competency Exam must have completed at least
two years of full-time work as a hearing health care provider and have a
current state-issued dispensing license or, where applicable, a
certificate of registration. Candidates who receive a passing score on
each of the test's five separate categories become board certified and
are awarded a certificate by NBC-HIS. Only 59% of applicants pass the
NBC-HIS National Competency Exam.

Exclusion of hearing aid specialists limits access to hearing tests for
those suffering from disabling hearing impairments. All three members of
the hearing healthcare delivery team -- hearing aid specialists,
audiologists, and otolaryngologists -- are recognized by the Federal
government as essential and fully qualified entry points into the
hearing healthcare delivery system. Indeed, the preamble to the current
U.S. Food and Drug Administration regulations governing the conditions
for sale of hearing aids states that \"the \[Food and Drug
Administration\] Commissioner regards the hearing aid dispenser as an
important member of the hearing healthcare team, strategically
positioned within the delivery system to provide the hearing impaired
with essential services.\" Importantly, hearing aid specialists as a
profession are more geographically dispersed than other hearing health
care providers. In particular, hearing aid specialists are often located
in more rural areas, while audiologists and otolaryngologists (ENTs)
tend to be clustered in more urban settings.

The U.S. Office of Personnel Management (OPM) also recognizes the role
of hearing aid specialists. In its March 2008 annual call letter for
benefit and rate proposals from Federal Employees Health Benefits
Program (FEHBP) carriers, the U.S. Office of Personnel Management (OPM)
strongly encouraged "proposals for enhanced hearing benefits for adults,
including hearing aids." OPM provided specific guidance with respect to
hearing healthcare providers in a subsequent April 11, 2008 letter,
which informed insurance carriers that: \"Licensed and qualified hearing
healthcare providers (hearing aid specialists, audiologists and
otolaryngologists) should be included in provider networks for hearing
aids and related services.\" The FEHBP covers approximately 8 million
government workers and their families and is often cited as a model for
healthcare reform efforts.

For the foregoing reasons, among others, IHS believes and requests that
hearing aid specialists should be eligible to provide the required
audiometric testing for purposes of evaluating adult disability claims
involving hearing loss. Please do not hesitate to contact me or our
Washington Counsel Karen Sealander of McDermott Will & Emery
(ksealander@mwe.com or 202.756.8024) with questions or for further
information. I also invite you to visit the IHS website at
www.ihsinfo.org.

Yours sincerely,

![](media/image1.jpeg){width="3.6034722222222224in" height="0.9in"}

James C. Ogurek, BC-HIS

President

Enclosure: Professional Practice Profile

cc: Chris Gustafson, BC-HIS, ACA, IHS President-Elect

Cindy J. Helms, IHS Executive Director

Susan Stewart, IHS Government Affairs Manager

Karen S. Sealander, IHS Washington Counsel at McDermott Will & Emery

**A P[rofessional]{.smallcaps} P[ractice]{.smallcaps}
P[rofile]{.smallcaps}**

**[for]{.smallcaps} H[earing]{.smallcaps} H[ealth]{.smallcaps}
P[rofessionals]{.smallcaps}**

*The International Hearing Society has adopted the following practice
profile as a\
comprehensive declaration of dispensing characteristics and expectations
that define the\
unique role of the hearing instrument practitioner.*

Hearing instrument dispensing includes several professions that overlap.
There are traditional hearing aid dispensers, Board Certified hearing
health professionals, hearing aid practitioners, hearing instrument
specialists, audioprosthologists, audiologists, doctors of audiology,
otolaryngologists and other doctors of medicine. This document
summarizes the scope of dispenser services as defined by the 1999
NBC-HIS Role Delineation Study of Hearing Aid Dispensers (D'Costa,
1999). It does not replace or supersede current state and federal
regulations governing the practice of hearing instrument dispensing, but
is specific to the training and legitimate professional activities of
those practitioners licensed in hearing instrument dispensing.

Simply put, the purposes of this document are twofold: to provide a
model hearing instrument dispenser practice plan for state/provincial
licensing boards and to provide consumers, government agencies and other
interested parties official information about the specific services and
understandings a patient has the right to expect from a competent
hearing health professional.

The following guiding principles and assumptions were used in the
development of this profile:

-   Only those professionals who hold professional licenses which allow
    hearing aid dispensing and who have appropriate training and
    experience may provide specific procedures.

-   Safety and health of the patient are the most important
    considerations in all practice decisions and actions.

-   All dispensing procedures are performed in a manner as to prevent
    bodily injury and infection.

-   Hearing aids may be only part of the answer for improved
    communication; therefore, it is important to recognize and to
    encourage the use of other assistive listening devices for patients.

-   Hearing healthcare requires a team effort. Dispensers must work with
    other professionals, as needed, to maximize patient care and
    interprofessional collaboration.

-   Dispensers form a partnership with each of their patients to help
    achieve total communication with their own world, thus enabling
    their development and participation in all aspects of their life.

-   All equipment must be maintained according to the manufacturer's
    specifications and recommendations. Equipment must be properly
    calibrated and necessary records maintained.

-   Decontamination, cleaning and disinfection of multiple-use equipment
    must be carried out according to facility-specific infection-control
    policies and manufacturer's guidelines.

-   Ambient noise levels in the test environment must be appropriate to
    the practice setting.

-   Documentation must be maintained in accordance with local
    regulations and in keeping with good professional practice.

The NBC-HIS 1999 Role Delineation Study analyzed the responses of survey
responders to 100 tasks in terms of the frequency with which each task
was performed, and in terms of the level of supervision occurring with
each task performance. Sixteen broad procedures were identified using
statistical clustering of the tasks and are listed below.

> 1\. **Elicit patient/client case histories,** including medical,
> otological, pharmacological, previous amplification history and
> patient attitudes and expectations.
>
> 2\. **Administer otoscopy** for the purpose of identifying possible
> otological conditions, including but not limited to the FDA red flag
> conditions that may indicate the need for medical referral or which
> may have a bearing on needed rehabilitative measures, outcomes and/or
> recommendations.
>
> 3\. **Administer cerumen management** in the course of examining ears,
> taking ear impressions and/or fitting of hearing instruments.
>
> 4\. **Administer and interpret tests of human hearing,** including
> appropriate objective and subjective methodology and measures.
>
> 5\. **Determine candidacy for hearing instruments,** assistive devices
> or referral for cochlear implant evaluation or other
> clinical/rehabilitative/medical intervention.
>
> 6\. **Prescribe, select and fit appropriate hearing instruments and
> assistive devices** including appropriate technology, electroacoustic
> targets, programming parameters and special applications as indicated.
>
> 7\. **Assess hearing instrument efficacy** utilizing appropriate
> fitting verification methodology, including all available fitting
> validation methods.
>
> 8\. **Take and prepare ear impressions for prosthetic adaptation** of
> hearing instruments, assistive devices, telecommunications
> applications, ear protection and other related applications.
>
> 9\. **Design and modify earmolds and auditory equipment** requisite to
> meet individual patient needs.
>
> 10\. **Provide rehabilitative advice and counseling** in the use and
> care of hearing instruments and assistive devices and in effectively
> utilizing communication coping strategies and other approaches to
> foster optimal patient rehabilitation.
>
> 11\. **Counsel family member(s) and other interested parties relative
> to psychosocial and rehabilitative considerations** for optimal
> patient outcomes.
>
> 12\. **Provide long-term patient care,** including periodic
> audiometric updates and recommendations for modifying rehabilitation
> programs to help meet patients' changing needs over time.
>
> 13\. **Refer and cooperate with other allied professionals** in
> meeting the needs of the hearing impaired.
>
> 14\. **Provide supervision and in-service training** of those entering
> the dispensing profession.
>
> 15\. **Maintain and update knowledge and skills in current and future
> diagnostic and technological advancements** within the hearing
> industry.
>
> 16\. **Consult with industry in the development of products and
> services** relating to aiding hearing impairment.

The sixteen procedures listed above were then grouped into six major
areas as follows:

> 1\. Assess patient presenting problem and needs
>
> 2\. Test and analyze patient hearing
>
> 3\. Prescribe and analyze hearing aid
>
> 4\. Fit, adjust, program and service hearing aid
>
> 5\. Counsel and help rehabilitate patient
>
> 6\. Manage office and practice

The following section addresses the expected outcomes, indication for
procedure and procedure methods for each of the six categories.

**ASSESS PRESENTING PROBLEM AND NEEDS**

**Expected Outcomes:**

-   Identification of factors in the patient's background that may put
    him/her at risk for hearing problems.

-   Identification of FDA red flags that would require a referral for
    medical evaluation.

-   Identification of other medical problems that may have an impact on
    the methods used for procedures and/or expected outcomes of hearing
    aid fitting.

-   Identification of family members' concerns regarding patient's
    hearing difficulties.

-   Exploration of patient attitudes and expectations of amplification.

-   Identification of problems with hearing and understanding.

-   Identification of daily activities and impact of hearing loss on
    lifestyle.

-   Identification of impact of hearing loss on family, friends and in
    the workplace.

**Indication for Procedure:**

-   Individuals being seen for either hearing screening or hearing
    evaluation

**Procedure Methods:**

-   Typically consists of a combination of written answers to a series
    of questions, elaboration of those answers by oral questioning and
    behavioral observation.

-   Areas covered include but are not limited to: family history of
    hearing loss; incidence and duration of childhood hearing-related
    illnesses; information regarding dizziness, loss of balance or
    tinnitus; current medication/drug history; and history of noise
    exposure and acoustic trauma. In addition, it is critical to elicit
    family members' concerns about the patient's hearing difficulties,
    the patient's attitudes and expectations regarding amplification,
    and the patient's own assessment of their hearing difficulties.

-   Additional areas that must be covered include but are not limited to
    questions regarding history of ear surgeries, diseases and
    treatments; information regarding past experiences with
    amplification; and questions and observations regarding ear
    deformity, pain, sudden hearing loss, ear infection, disease,
    drainage or blockage requiring medical referral.

**TEST AND ANALYZE HEARING**

**Expected Outcomes:**

-   Basic hearing evaluation is conducted to quantify and qualify
    hearing loss on the basis of perceptual responses to acoustic
    stimuli and to describe any associated communication disorders.

-   Results of the evaluation may result in recommendations for more
    advanced testing, medical referral, amplification consultation,
    assistive listening device consultation or follow-up
    recommendations.

-   Speech discrimination tests are performed for additional information
    about a hearing loss.

-   Evaluation may result in recommendation for a medical referral,
    amplification, aural rehabilitation and/or counseling.

-   Determine need for medical referral based on audiometric air-bone
    gap results.

-   Determine degree, type and configuration of hearing loss from test
    results.

-   Hearing instrument efficacy will be determined by pre-post
    audiometric measures.

**Indications for Procedure:**

-   Hearing evaluation may be done when a hearing screening is failed.

-   Hearing evaluation is generally prompted by self-referral, family
    referral, failure of an occupational hearing test or referral from
    other professionals.

**Procedure Methods:**

-   Hearing evaluation is preceded by eliciting the hearing history and
    assessing the hearing problem. This is followed by examination of
    the external ear canal and cerumen management if necessary.

-   The standard audiometric tests consist of pure-tone air and bone
    conduction testing with appropriate masking using the TDH-39
    standard. It is our recommendation that all providers move to the
    EAR-3 or equivalent insert earphones standard by July 1, 2005. Some
    professionals also choose to do loudness growth testing at this
    time.

-   Speech testing includes speech awareness and/or speech reception
    threshold tests, speech discrimination tests and establishing MCL
    and UCL thresholds (appropriate masking used as required). In
    addition, further information can be gained by doing unaided and
    aided sound field discrimination tests and by testing binaurally as
    well as monaurally.

-   Special audiometric tests are performed for additional information
    about a hearing loss.

-   Evaluation may result in recommendation for a medical referral,
    amplification, aural rehabilitation and/or counseling.

-   Procedures such as immittance audiometry (tympanometry and reflexes)
    are quite common.

-   Procedures to assess cochlear versus retrocochlear (i.e., eighth
    cranial nerve, brainstem or cortical) auditory disorders include
    acoustic reflex threshold, tone decay testing and PiPb rollover
    testing.

-   Special procedures for testing infants and children as appropriate
    to licensure or evaluating tinnitus are also sometimes called for.

-   Evaluate the reliability and validity of the test results.

-   Evaluate test results to determine the presence of collapsed ear
    canals.

-   Evaluate aided sound field measures and/or real-ear aided
    performance measures or live speech mapping.

**PRESCRIBE AND ANALYZE HEARING AID**

**Expected Outcomes:**

-   In consultation with the patient and family (taking into account
    their lifestyle, special needs, hearing aid style, technology and
    price category preferences), selecting the hearing aid that will
    best fit their needs.

-   Provide measurable results of improved hearing thresholds and ease
    of communication.

-   The appropriate specifications for the hearing aid will be selected.

**Indication for Procedure:**

-   Individuals identified with hearing loss who have reached a level of
    acceptance regarding their loss and are ready to seek help from
    amplification.

**Procedure Method:**

-   Determine hearing aid needed for severity, type and configuration of
    hearing loss, keeping in mind the patient's history, lifestyle and
    audiogram.

-   Discuss with patient the various levels of technology and their
    different price categories to aid in determination of hearing aid
    prescription.

-   Identify physical limitations affecting hearing instrument
    selection.

-   Prior to dispensing the hearing aid, verification of hearing aid
    performance is conducted via a listening check to rule out excessive
    circuit noise, intermittency and/or poor sound quality.

-   Perform electroacoustic analysis to determine if hearing aid is
    performing according to manufacturer's specifications.

-   Confirm telecoil function.

-   Programmable and digital hearing aids should be programmed prior to
    patient's arrival to ensure integrity of programming system and
    hearing aids.

**FIT, ADJUST AND SERVICE HEARING AID**

**Expected Outcomes:**

-   Appropriate earmold/hearing aid shell configuration and material
    will be selected for maximum comfort and hearing aid performance.

-   Alleviation of a problem with physical or acoustic comfort (i.e.,
    occlusion, loudness, discomfort).

-   Restore the aid to manufacturer's specifications.

**Indications for Procedure:**

-   Patient is being fitted for new amplification.

-   Patient or family reports a problem with the function, comfort or
    benefit being received from the hearing aid.

**Procedure Methods:**

-   Assess ear canal for ear impression vis-à-vis size, length and
    direction.

-   Perform proper ear impression procedures, e.g. otoblock placement.

-   Determine earmold/hearing aid shell configuration and material.

-   Examine surface of earmold and instrument for damage and sharp
    edges.

-   Perform physical fitting of coupler and instrument.

-   Appropriateness of physical fit should be assessed through ease of
    insertion and removal, cosmetic appeal, comfort, absence of
    feedback, placement of microphone port(s) and ease of volume control
    use when present.

-   Program selected hearing aids to patient's baseline audiometric
    data.

-   Adjust/modify hearing instrument electronics based on patient
    feedback.

-   Make venting modifications as needed for reduction of occlusion
    effect and/or to control feedback. Modify shell or earmold for
    improved, more comfortable fit.

-   In the event the patient returns with a malfunctioning hearing aid,
    conduct in-office internal inspection of earmold and instrument and
    take appropriate corrective action (suctioning wax and debris from
    receiver and microphone ports, cleaning corrosion from battery
    contacts, replacing earmold tubing, etc.). Conduct electric current
    drain measurement of hearing aid. If in-office repair is not
    possible, return aid to manufacturer for repair and offer the
    patient a loaner hearing aid to use while his/hers is being
    repaired.

-   If the hearing aid needs to go to the factory for repair and it is
    out of warranty, inform the patient of the charges and repair
    warranty.

-   Validation of fitting should be done with sound field testing using
    frequency specific thresholds and/or aided speech discrimination and
    speech reception thresholds or with realear aided measurements or
    with live speech mapping.

-   Reprogram hearing aids based on patient feedback.

**COUNSELING AND AURAL REHABILITATION**

**Expected Outcomes:**

-   Dispensers assist patients in coming to grips with the reality of
    their hearing loss and in the process of accepting amplification or
    other assistive listening devices.

-   Dispensers educate the family and the patient in the ramifications
    of a hearing loss and what is a reasonable expectation for improved
    communication with amplification.

-   To facilitate listening in various acoustic environments.

-   To provide alerting systems to: augment the benefits of the hearing
    aids, establish procedures for follow-up and provide information to
    allied healthcare professionals.

**Indications for Procedure:**

-   Individuals who have had their hearing evaluated.

-   Individuals who are being fitted with amplification.

-   Individuals who need more help than their hearing aids can provide
    in various situations.

**Procedure Methods:**

-   Explain otoscopic examination and audiometric assessment to patient.

-   Discuss patient's reactions to hearing instruments.

-   Discuss with patient various treatment options, e.g., different
    levels of technology, different styles of hearing instruments.

-   Provide patient with hearing rehabilitation exercises.

-   Explain hearing instrument use in different listening environments.

-   Instruct patient on proper instrument insertion and removal
    techniques.

-   Counsel patient on cerumen management.

-   Counsel patient regarding care and use of instrument.

-   Counsel patient on battery life and insertion/removal techniques.

-   Counsel patient on telephone usage with hearing instruments and
    assistive listening device coupling as necessary.

-   Counsel patient on amplification expectations and limitations:

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-   discussion of appropriate expectations for amplification include
    improved communication, freedom from unwanted feedback, minimization
    of the occlusion effect and more auditory benefit in quiet than in
    noise

-   patient is advised of their legal rights for hearing aid adjustment,
    replacement and return

-   self-assessment tools that measure degree of hearing handicap and/or
    pre- and postfitting satisfaction are an appropriate tool for
    measuring patient satisfaction

-   instruct patient/family in effective listening techniques with
    hearing aids

-   counsel family members about patient's adjustment and use of hearing
    aids

-   provide patient with information concerning environmental
    modifications that can ease communication

-   may provide patient with information on speech reading or other
    aural rehabilitation classes

-   may include demonstration and information on devices to enhance
    telephone usage; listening to television; listening in church;
    listening in restaurants and other difficult listening environments;
    listening in the classroom or auditoriums; and telephone, doorbell
    and smoke alarm alerting systems

-   formulate long-term treatment program

-   establish methods for recording care from treatment to
    rehabilitation

-   counsel patient on importance of follow-up visits

-   provide physician, with patient's permission according to HIPAA
    standards, your audiometric evaluation and recommendations and
    communicate with other allied health professionals as appropriate.

**OFFICE AND PRACTICE MANAGEMENT**

**Expected Outcomes:**

-   Equipment will be maintained according to sanitary guidelines and
    manufacturer's specifications.

-   Records will be maintained in an organized and efficient manner.

-   Clinical/professional knowledge and skills will be current.

**Indications for Procedure:**

-   To standardize professional standards and practices.

**Procedure Methods:**

-   Maintain equipment to standards of sanitation and cleanliness.

-   Supervise sanitization and cleanliness of office personnel.

-   Maintain equipment according to manufacturer's specifications.

-   Conduct biologic check of audiometric equipment.

-   Perform cerumen management procedures using standard
    techniques/equipment.

-   Recruit, train and develop professional and administrative staff.

-   Establish supervisory procedures to ensure quality care.

-   Develop marketing and advertising plans.

-   Provide certification to patient to receive amplified telephone
    systems where appropriate.

-   Identify sources of patient referrals.

-   Establish and maintain quality assurance procedures.

-   Adopt and follow a professional code of ethics.

-   Maintain adequate professional liability protection.

-   Design, implement and monitor hearing care/conservation programs.

-   Know governmental laws and guidelines affecting the dispensing
    profession.

-   Update clinical/professional knowledge and skills.

-   Attend professional seminars, conferences and association
    conventions.

-   Maintain patient records in accordance with governmental regulations
    including HIPAA privacy standards.

-   Develop and maintain effective patient/business information systems.

-   Maintain and adhere to all HIPAA standards when billing
    electronically.

-   Formulate short- and long-range business plans.

-   Upgrade office computer systems (hardware and software).