There has been a lot of activity on the issue of the hearing benefit recently offered by hi HealthInnovations (subsidiary of United Healthcare/United Health Group) as well as the whole issue of internet hearing tests and hearing aid sales by other entities.
There are many ways to address this issue and as audiologists, this is our new reality, for this component of our scope of practice. (Be sure to read 'Our New Reality' column in the Nov/Dec issue of AT, page 8 – the column was written well before the UHC announcement!)
Below, please find previous action items, information and resources to help you educate your patients and the consumers in your local area as they work through all these hearing healthcare issues.
As indicated in my January 2012 AT Enews column, we will continue to work diligently behind (and in front of) the scenes to educate, participate, and engage Academy members and the patients they serve to ensure that proper hearing healthcare is provided. The Academy has also been in contact with staff at UHC to discuss these issues.
As you review the information/resources below, please feel free to contact me or any of the Board of Directors so we can disseminate information through the appropriate channels to ensure all members have contemporary knowledge of the issues.
Previous Action Items
Item 1: The Academy and ADA sent (express mail) a letter to Lisa Tseng, MD (Chief Executive Officer, hi Health Innovations) and a letter to Rhonda Medows, MD (Chief Medical Officer and Executive Vice President, United Healthcare). The ultimate goal of the letter was to lay out a sustainable hearing benefit for UHC and hi HealthInnovations and to help them understand that audiologists are ready and willing to help them implement a best practices model for their hearing benefit. We hope to hear from the leadership of UHC and hi HealthInnovations in order to get discussions going.
Item 2: Numerous emails and calls have taken place with our allied associations and colleagues. In addition to discussions with our colleagues in the ADA, we have been in touch with the leadership of the Hearing Industries Association (HIA), the American Academy of Otolaryngology, Head and Neck Surgery (AAO-HNS), the International Hearing Society (IHS) and the American Speech-Language-Hearing Association (ASHA).
Item 3: We have reached out to the Food and Drug Administration (FDA) and have been told the following:
1. Internet sites selling hearing aids must comply with the "spirit" of the medical waiver regulation. When Academy members become aware of websites that waive medical evaluation by the consumer simply making the hearing aid purchase, the FDA would like us to forward this information to the Agency. The compliance division will then investigate. If the online site requires that the consumer check a box to confirm that they can waive the medical evaluation, then the online site is required to comply with all the waiver provisions as outlined in the Code of Federal Regulations – Title 21. Beyond this, there is nothing more the FDA can do to regulate this as the online site is complying with the "spirit" of the regulation.
2. The FDA recognizes that there may be consumers purchasing PSAPs (personal sound amplification products) for off-label use, i.e., consumers with hearing loss using PSAPs instead of hearing aids to treat loss. There is no way for the FDA to control off-label use of these products. The FDA has provided additional information to consumers on the FDA website to address these concerns and provide guidance to consumers.
3. Through their Compliance Division, the FDA is currently reviewing sites that evaluate hearing online.
Item 4: The issue of internet hearing aid sales is not new to us. Members are working within their states to address the issues raised by the UHC announcement and for illustrative purposes; we provide a summary of the work going on in the state of Ohio:
The Ohio Internet Hearing Aid Work Group (Work Group)*, in an effort to establish legislation that would limit the scope of internet hearing aid sales in Ohio and protect Ohio consumers, has spent the last 10 months researching states laws and regulations that currently provide additional restrictions regarding mail order and/or internet sales of hearing instruments. A Mail/Internet Hearing Aid Sales Comparison Chart (including the specific statutes) and a document including the specific state restrictions can be found on the Academy website. The research has led the Work Group to several conclusions:
1. Revisions of statutes specific to audiology and/or hearing instrument specialists will not result in any change in the mail/order internet hearing aid delivery model or restrict their practices, i.e. state licensure boards only have authority over individuals licensed to practice.
2. Revisions of the consumer protection laws will result in providing greater consumer protection and because these laws are enforced by the state Attorney General's office, will have greater authority.
While each state will need to determine how to approach internet/mail order hearing aid sales, we wanted to share the information Ohio has gathered in an effort to help other states advance within-state initiatives.
*The Ohio Internet Hearing Aid Work Group is comprised of audiologists, hearing instrument specialists, legislative agents representing these professions, and representatives from the Ohio Board of Speech Pathology and Audiology and the Ohio Hearing Aid Dealers and Fitters Licensing Board.
Your state Attorney General: Check the National Association of Attorneys General website for a list of addresses and phone numbers for each state's Attorney General Office.
State Network Committee: Use these contacts to promote communication among states and the national Academy.
Your local Consumer Protection office: Find an office near you at consumeraction.gov. Look under "Where to File a Complaint." 2011 Consumer Action Handbook (This everyday guide to being a smart shopper is chock-full of helpful tips about preventing identity theft, understanding credit, filing a consumer complaint, and more.)
More Resources for Members and Consumers
Academy Consumer Web site (www.howsyourhearing.org): Provides information on hearing loss and treatment (hearing aids) for consumers.
FDA (Food and Drug Administration): Information on Hearing Aids
FDA: Hearing Aids and Personal Sound Amplifiers: Know the Difference
FDA: Buying Medical Devices and Diagnostic Tests Online
FDA: Buying Diagnostic Tests Online: Buyer Beware!
FTC (Federal Trade Commission): Sound Advice on Hearing Aids
Many states also have laws governing hearing aid sales and implied warranties. Your state Attorney General's office or Audiology licensing Board can tell you what laws apply in your state.
Sound Advice: Buying a hearing aid online or through the mail is risky. In fact, some states don't allow hearing aids to be sold through the mail at all. That's because an aid needs to be custom fitted and tested to be sure it's working properly.
FTC: What if I want to complain about a device?
To report problems with medical devices, including hearing aids, contact the FDA via the MedWatch Online Reporting Form 3500 or call: 1-800-FDA-1088.
The FTC works to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help consumers spot, stop and avoid them. To file a complaint or get free information on consumer issues, visit ftc.gov or call toll-free, 1-877-FTC-HELP (1-877-382-4357); TTY: 1-866-653-4261. Watch a video, How to File a Complaint, to learn more. The FTC enters consumer complaints into the Consumer Sentinel Network, a secure online database and investigative tool used by hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.
Consumer Reports: Purchasing a Hearing Aid: A Checklist
Therese Walden, AuD