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ISHA Newsletter

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  • 26 Nov 2013 3:22 PM | Ann Ninness (Administrator)

    Published on Monday, 18 November 2013 16:44

    The US Food and Drug Administration (FDA) released on November 7 a draft Guidance Document that, when finalized, is designed to further clarify the regulatory distinctions between hearing aids and personal sound amplification products (PSAPs). The original language defining PSAPs by the Agency was issued in its February 2009 Guidance for the Industry and FDA Staff.

    The latest Guidance document on hearing aids and PSAPs does not depart significantly from the definitions previously set forth by the FDA in 2009. The Agency regulates hearing aids as medical devices, while PSAPs are designed to enhance normal hearing rather than to address hearing loss and are therefore not subject to FDA regulation. However, the Agency in its original 2009 Guidance banned the marketing of PSAPs as hearing aids, with the intent to prohibit PSAP manufacturers from targeting hearing-impaired individuals.

    It would appear that the latest Guidance Document takes a tougher stance on those PSAP manufacturers that market their products to hearing-impaired consumers and use subtle (and not so subtle) references to their hearing loss. The Draft Guidance emphasizes that “FDA relies on the intended use of each product to determine whether it is a medical device or an electronic product.” The Agency lists a variety of potential claims and language that would establish an intended use as a medical device such as:

    · A description of the types and severity of hearing loss;

    · A description of listening situations that are typically associated with and indicative of hearing loss; and

    · Wording to suggest that the product is an alternative to a hearing aid.

    Specifically, the Guidance document defines hearing aids and PSAPs as:

    Hearing aids.Hearing aids are still defined by FDA as wearable sound amplification devices intended to compensate for a hearing loss, covering both air and bone conduction and essentially all styles of hearing aids (eg, BTEs, RICs, ITEs, CICs, etc). The Draft Guidance document describes the current three categories of Class I and Class II devices relative to premarket review and clearance prior to marketing the products:

    1) Class I devices which are all exempt from FDA premarket review and clearance;

    2) Class II devices that are exempt from premarket review and clearance;


    3) Class II devices that require premarket review and clearance.

    The regulatory definition for generic hearing aids (air and bone conduction devices) falls under #1 above; wireless air-conduction hearing aids fall under #2 above, and have various special controls for items such as electromagnetic compatibility, design, labeling, etc; and systems like transcutaneous air conduction hearing aid systems fall into #3 above.

    The document describes how all hearing aids are subject to various FDA requirements, such as the currently established patient and professional labeling requirements (eg, provision of the User Instructional Brochure), the physicians’ statement of medical evaluation or waiver, and standard conditions of sale for dispensing professionals (eg, retaining records of medical evaluation statements and waivers for a 3-year period following the dispensing of an aid).

    PSAPs.The Draft Guidance document states that “PSAPs are intended to amplify environmental sound for non-hearing impaired consumers” and are not subject to FDA regulation. However, the document also goes on to say:

    “Examples of listening situations that are typically associated with and indicative of hearing loss include: difficulty listening to another person nearby, difficulty understanding conversations in crowded rooms, difficulty understanding movie dialogue in a theater, difficulty listening to lectures in an otherwise quiet room, difficulty hearing the phone or doorbell ring, or difficulty listening in situations in which environmental noise might interfere with speech intelligibility. Products making these or similar claims should not be considered PSAPs. In addition, products that are sold as an “over the counter” alternative or substitute for a hearing aid should not be considered PSAPs. Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the FD&C Act. As such, there is no regulatory classification, product code, or definition for these products. Furthermore, there are no requirements for registration of manufacturers or listing of these products with FDA.”

    PSAPs are not subject to the same regulations as hearing aids. However, PSAPs are subject to provisions in the 1968 Radiation Control for Health and Safety Act, and must report defects and adverse events and take other measures prescribed. They must also comply with requirements for repurchase, repair, or replacement of electronic products as set forth by 21 CFR Parts 1000, 1003, and 1004.

    Comment period.The document states that the Draft Guidance contains non-binding recommendations, but, when finalized, will represent its current thinking on the topic. Written comments and suggestions may be submitted to the Agency within 90 days of the announcement of the document in the Federal Registry (published November 7).

    FDA also publishes new Consumer Update. On November 6, the day before issuing the above described Draft Guidance document, FDA issued a Consumer Update titled “Hearing Loss Signals Need for Diagnosis” about the perils of delaying the diagnosis of a treatable or serious ear condition. The document covers why some hearing losses could be life threatening, the difference between hearing aids and PSAPs, and facts that consumers should be aware of before purchasing a hearing aid, including the difference between an audiologist and hearing aid dispenser, and other advice for seeking hearing help.


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  • 22 Nov 2013 11:12 AM | Ann Ninness (Administrator)


    The Medicare outpatient therapy cap exceptions process expires on December 31, 2013. Without Congressional action, patients will be faced with a hard cap on outpatient therapy services in 2014. The American Speech-Language-Hearing Association and the Therapy Cap Coalitionundefineda group of almost 50 associations, organizations, and patient and consumer groupsundefinedare working together to prevent the therapy cap from going into effect, but we need your help!


    Congress has introduced a proposal to reform the sustainable growth rate (SGR) formula, which does not include repealing the Medicare therapy cap. If Congress passes legislation addressing the SGR formula, but does not include a repeal of the Medicare therapy cap, it is likely that patients will face a hard cap on outpatient therapy services in 2014. Contact your members of Congress TODAY and ask them to include a full repeal of the Medicare therapy cap in the SGR reform legislation orundefinedat the very leastundefinedextend the exceptions process. Don’t let them forget about the beneficiaries and the harm that the Medicare therapy cap will cause!


    For more information on this issue, please visit ASHA’s Therapy Cap Advocacy Center or view ASHA’s issue brief on the Medicare Outpatient Therapy Cap. Please contact Ingrida Lusis, ASHA’s director of federal and political advocacy, at with questions.


    Take Action Here


  • 05 Nov 2013 10:42 AM | Ann Ninness (Administrator)

    For the past fifteen years, the Speech, Language, and Hearing Sciences Department at Purdue University has been organizing the fall Crossroads Conference for students, Professors, Researchers, vendors, Speech-Pathologists and Audiologists to form a community of networking.  Anyone interested in the pressing issues and most recent research in the field of Speech-Pathology and Audiology may attend, and is a great opportunity for all attending to learn from one another.  Professors and Researchers from across the nation counsel one another; vendors are able to promote their products such as Varibar, and employment companies such as Theracare collect contact information from eager graduate students.


    Networking in between lectures

    The Crossroads Committee and Undergraduate students play a big role in the planning and success this conference.  “The hardest part was coordinating all the volunteers, but we got a big response from our undergraduates and volunteer spots filled up in one day” Purdue Undergraduate NSSLHA President Courtney Wisher noted, who played a big role in planning the conference. 



    NSSLHA officers from left to right:

    Recording Secretary Hillary Greeson, President Courtney Wisher, Webmaster Erin Boyle,

    Corresponding Secretary Rachel Platt (myself), Vice President Rebecca Henaghan


    NSSLHA officers from left to right:

    Historian Jessica Tolle and Treasurer Rachel Morrow

    The conference is a great opportunity for all undergraduates in the major to get their foot in the door and interact with professionals in the field.  Vice president Rebecca Henaghan said that “the cool thing about crossroads is that people from all over the United States attend; you realize how large and influential our field is.”


    As an undergraduate student, it is easy to get caught up in GPA and GRE scores and applying to graduate school.  The Crossroads Conference is a reminder of what we are working so hard for: a rewarding and growing field and the ability to brighten the lives of those with hearing and language disorders.  It is also an affirmation of what we are learning in our academic classes.   For me it was satisfying listening to Dr. Sumitrajit Dhar lecture on Otoacoustic Emissions theory and practice when I had just learned how to use this technology in my Introduction to Assessment Audiology class.


    The Crossroads Conference is a forum of not only shared information and opportunities, but of passion for the field.  The inspiration from the students, faculty, and presenters alike is why this conference has been such a success and why it should be continued for years to come.


    This blog was written and submitted by Rachel Platt, Purdue University NSSLHA Corresponding Secretary. 


  • 04 Nov 2013 10:36 AM | Ann Ninness (Administrator)

    The EHDI E-mail Express, which is a monthly eNewsletter developed by the American Academy of Pediatrics (AAP), is now available at under the resources tab. The EHDI Express contains information about EHDI resources, upcoming events, and current clinical research.

    Dr. Luis F. Escobar is the American Academy of Pediatrics Indiana Early Hearing Detection and Intervention (EHDI) Chapter Champion. Please feel free to reach out to Dr. Escobar with any questions. He can be reached by e-mail to

  • 01 Nov 2013 1:58 PM | Ann Ninness (Administrator)

                   Michael R. Pence

    Nicholas W. Rhoad
       Executive Director


    Current Speech Pathologist and Audiologist licenses expire December 31, 2013

     Renew Online Now!

    Online Renewal

    • Our online renewal service is quick and available 24/7 with a credit or debit card (we accept Visa, Mastercard and Discover). 
    • Your license number is the login ID and your;password is the last 4 digits of your social security number.
    • The renewal fee is $105.57 per license ($100 renewal fee plus $5.57 in processing fees).
    • Please update your address, e-mail address, and phone number while you're there.
    • Name changes require submission of a copy of the legal name change document (marriage certificate, divorce decree, social security card) to this office via fax at (317)233-4236 or email at:
    • The renewal will be processed and available for verification the next business day.

    License/Pocket Cards


    The Indiana Professional Licensing Agency no longer prints and mails license/pocket cards. After your license renewal has been processed, you may log back into our website at , click on "License Express" on the top left bar, then click on "Order License Card" to order a license/pocket card.  You may print it for free, or you can order one to be mailed to you for a charge of $13.77.  Available online only.

    Late Fees

    If your online renewal or paper renewal is postmarked after December 31, 2013, a late fee of $50.00 will be assessed along with the online processing fees.  Please add to the payment making the total $156.57 (online) or $150.00 (by mail) after December 31, 2013.

    Renew by Mail

    Allow 4 weeks for mailing and processing.  To renew your license by mail please print the renewal form from our webpage by selecting Renewals.  Please return the completed form with your check or money order in the amount of $100.00 payble to "Indiana Professional Licensing Agency".  If postmarked after 12/31/2013 the total will be $150.00.  The mailing address is on the paper form.

    Email Address

    Make sure yours is up-to-date.  Email is our preferred method of communication and you'll receive notifications quickly.


    How can we help?  Contact us by email at or visit us at 



    "We're striving to cut red tape and remove barriers to practice to make Indiana a state that works!; Have ideas?; Please give us your suggestions at"

      -Nicholas W. Rhoad, Executive Director


  • 31 Oct 2013 4:18 PM | Ann Ninness (Administrator)

    Photo credit:


    The latest proposed rule to reduce Medicaid reimbursement for this biennium, which runs through 6-30-15, is now posted at under the resources tab.  ISHA requests your thoughts and input.  Some of the provisions of LSA Document #13-422 that might apply to members are as follows:

    1.         Home health reimbursement is being reduced by 3%.

    2.         Outpatient hospital services are being reduced by 3%.

    3.         Various provisions regarding hearing aids are being
            modified as highlighted in the LSA Document #13-422

  • 16 Oct 2013 10:35 AM | Ann Ninness (Administrator)

    Photo credit:

    Affordable Care Act Communication Directory

    A Quick Reference Guide for the ACA is now located on the ISHA Website under Resources tab.  You can access it directly - Click Here!

  • 02 Oct 2013 2:10 PM | Ann Ninness (Administrator)

    Photo credit:


    The SSA is requesting comments on whether and how it should revise the criteria in its Listing of Impairments (listings) for evaluating hearing loss and disturbances of labyrinthine-vestibular function in adults and children.  Comments are accepted through October 29, 2013. 

    The SSA is inviting comments and suggestions from individuals who apply for or receive benefits from the agency; advocates and organizations that represent individuals who have hearing disorders or disturbances of labyrinthine-vestibular function, state agencies that make disability determinations for the SSA, experts in the evaluation of hearing disorders, researchers, and other members of the general public.

    Get information at and enter the docket number SSA-2012-0075 in the search bar

    You can make comments directly to the website or feel free to comment at the end of this blog. 

    Questions to consider: 

    ·         Do the rules for evaluating hearing loss or disturbances of labyrinthine-vestibular function contain technical language or jargon that is not clearly explained? If not clearly explained, what technical language or jargon needs further explanation?

    ·         Are the requirements for otological examinations and audiometric testing provided in §§2.00B and 102.00B clearly stated? If not clearly stated, what requirements need further clarification?

    ·         What types of testing should the agency consider when evaluating hearing loss in adults or children who cannot cooperate in behavioral testing?

    ·         Would it be helpful to add a sample audiogram that contains all the requirements necessary for evaluation of hearing loss in adults or children?

    ·         What word recognition tests other than the Hearing in Noise Test (HINT) or the Hearing in Noise Test-Children (HINT-C) should the agency consider when it evaluates hearing loss treated with cochlear implantation?

    ·         Should the SSA provide examples of medical reasons for a discrepancy between the speech reception threshold and the pure tone average?

    ·         Could the SSA improve clarity by replacing the phrase “disturbances in labyrinthine-vestibular function” with the phrase “disturbances of inner ear function”?

    ·         Rather than evaluating disturbances in labyrinthine-vestibular function in adults under the listings, would evaluating disturbances in labyrinthine-vestibular function using residual functional capacity improve the determination process?

    ·         Should the SSA continue to evaluate disturbances of labyrinthine-vestibular function under the Special Senses and Speech body system?

    ·         What else could the SSA do to make the rules for evaluating hearing or disturbances in labyrinthine-vestibular function easier to understand?

    ·         Would a different format make the rules easier to understand (for example, changing the grouping or ordering of sections; use of headings; paragraphing; use of diagrams; use of tables)?

    ·         Experts who study disability believe that many personal, environmental, educational, and social factors contribute in significant ways to the relationship between an individual's hearing ability and the ability to work. Rather than providing criteria for evaluating hearing loss in adults under the listings, should the SSA evaluate all hearing loss using residual functional capacity?

    For further information, contact Cheryl A. Williams,
    Office of Medical Listings Improvement, SSA, 6401 Security Blvd., Baltimore, Maryland 21235-6401, (410) 965-1020

    Hala Elsisy
    Indiana Speech Language Hearing Association
    VP of Audiology

  • 02 Oct 2013 2:03 PM | Ann Ninness (Administrator)


    LIKE ISHA on FB to be entered in a drawing on 1/6/2014 for

    FREE REGISTRATION to the 2014 Annual ISHA Convention.


    It’s so simple!  We want to be your friend!  Make sure you are a friend of ISHA on Facebook by January 6th to be entered in a random drawing from all of our FB friends.  The prize is one free registration to the 2014 Annual ISHA Convention. We love our Facebook friends and it is a great way to stay connected. 

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