UPDATE: Based on conversations between the American Academy of Audiology (and other highly concerned organizations) and the U.S. Food and Drug Administration (FDA), the FDA has issued a cease and desist letter with regard to the online hearing test offered by hi HealthInnovations. The Academy began discussions with the FDA in early November 2011. Click here for more information.
On January 31, 2012, representatives from the American Academy of Audiology (AAA) and the Academy of Doctors of Audiology (ADA) met with representatives from United Healthcare (UHC) and hi HealthInnovations (UHC/HI). This meeting was the culmination of many email contacts and discussions between the AAA, ADA and UHC/HI, which began in October 2011 when the new UHC ‘hearing aid benefit’ was introduced during the nationwide open enrollment period for Medicare Advantage insurance plans. This new hearing aid benefit offered by UHC/HI includes both an online hearing test (used to determine need for a UHC/HI hearing device) and the online purchase of a specified package of hearing devices UHC/HI has procured through IntriCon Corporation. Since the time of the January 31st meeting, the Boards and staff of the AAA and the ADA have been hard at work vetting and summarizing the information gleaned from the meeting and all prior communications. We want to ensure that our respective memberships have the most up-to-date and verified details in reference to the new UHC hearing aid benefit program. In this document you will find summary information from the January 31st meeting between the AAA, ADA and UHC that will include our concerns regarding the hi HealthInnovations hearing device benefit, the proposed role of audiologists in this program, some background on the program development and the components of the program (the online test and the devices offered). Additionally, there is a timeline of events provided as well as some resources/links for your use.
UHC/HI Hearing Benefit Business Model
During the meeting, the AAA and the ADA learned more details about the structure of UHC/HI and its hearing device benefit business model. As background and purpose for the online hearing device benefit, Dr. Lisa Tseng, Chief Executive Officer for hi HealthInnovations, reported to AAA and ADA that UHC subscribers requested a ‘hearing aid benefit’ through a series of town hall meetings and through other venues. Dr. Tseng reported that the UHC/HI goals were to: 1) respond to their subscribers’ needs, 2) improve accessibility to hearing care – through the online hearing test/questionnaire on hearing ability and 3) reduce the cost of providing hearing aids to subscribers by offering non-custom, open-fit hearing aids online that were ‘customized’ in terms of gain/frequency response based on the online questionnaire responses and the online hearing test.
AAA and ADA representatives shared a multitude of our memberships’ concerns about this online program, including but not limited to:
- The lack of professional intervention at any level (evaluation, diagnosis, necessary referrals, medical contraindications, treatment options, on-going counseling/rehabilitation, education and on-going patient-focused care);
- Issues related to the validity and reliability of the online hearing test (especially since the ‘test’ incorporated only two air-conduction frequencies upon which the ‘customized’ hearing device programs would be based);
- The assumption by the hi HealthInnovations team that the device was the ‘cure’;
- The need to address conductive/mixed losses and other medically relevant issues such as asymmetry;
- Issues related to dispensing a hearing aid without a license (states have decided that patient safety/patient care is best served by professionals who are licensed and meet specific practice guidelines); regulatory issues;
- Issues related to follow-up care.
While many questions were broadly addressed during the meeting, UHC/HI did not provide enough information or demonstrate any action that alleviates our concerns about their hearing device delivery model and its impact on patient care and both short and long term patient outcomes. At this time, it appears that UHC/HI is relying on the research conducted to date that supports their assertions that their hearing device benefit and process is scientifically sound as a service delivery model. Additionally, UHC/HI contends that their program delivery model meets current state licensure and federal regulatory requirements. Many questions remain as to the validity of this assertion and this is being explored by the AAA and the ADA, as well as other organizations in terms of licensure requirements (e.g., who is actually responsible for dispensing the device) and adherence to current regulatory issues such as FDA regulations in terms of device labeling, etc.
Additionally, UHC/HI stated that they were developing a network of audiologists both within the UHC/HI structure (for subscribers) as well as external ‘field staff’ for non-subscribing consumers who need care beyond the online test/device purchase. Dr. Tseng indicated that for those subscribers/consumers who needed/preferred a custom device, there would be a referral process in place to address this need.
UHC/HI also indicated that they are constantly expanding the program to address the needs of their subscribers (based on the currently available research) and suggested that there would be more extensive packages of devices available in the future. Dr. Tseng reported that the software used to ‘customize’ the hearing device programs would be made available as a download to network audiologists as well as anyone who was interested beyond the network. It is not clear if audiologists outside of the network would have to pay for the software or access to the software. A clinic version of the online hearing test – available now – would be disseminated to participating providers to improve access to hearing testing in a PCP’s office, etc. Information will be provided to the PCP office that would help the patient obtain a hearing device online or through a network audiologist if the online products were not appropriate.
For consumers who purchased the devices online, a ‘lifetime service plan’ is offered for repairs and network audiologists would be reimbursed by the plan for providing necessary services associated with this care. Consumers have 45 days after the initial date of purchase to return the device for any reason for a full refund. UHC/HI stated that consumers who obtain the hearing device through the online process will be referred (as indicated by the results of the online test) to see an audiologist or a physician. Ongoing support from UHC/HI would also be provided to consumers by phone and online through web tutorials, online resources and networks and ‘field staff’.
Role of Audiologists
Audiologists have the option to sign-up with UHC as contracted professionals to provide audiology services to all UHC plan subscribers (including hi HealthInnovations), however it depends on the market needs in each region as to whether UHC will contract with new audiologists. UHC did not have specifics as to which markets would be open to new providers at the time of the meeting.
During the January 31st meeting, UHC/HI representatives agreed to follow-up with a comprehensive document that would outline the details of the UHC program and a patient’s pathway to a hearing health professional. This document would provide audiologists with an understanding of UHC/HI’s process for their participation as providers in the program as well as concrete operational details regarding the UHC/HI program that they could provide to their patients. The UHC/HI document can be found here. Neither the AAA nor the ADA feel that this document provides the level of specificity required for an audiologist to understand his or her role in the UHC/HI program nor could the audiologist provide sufficient information to their patients based on its content. Issues such as what constitutes a covered benefit are not clearly delineated in this document although UHC/HI stated that they would work with providers and consumers to ensure that an outline of specific responsibilities is developed.
UHC/HI representatives stated that they their new online program was not designed to replace hearing healthcare professionals. However the AAA and the ADA remain adamant that the UHC/HI hearing healthcare delivery model poses significant risks for patients. Audiologists who have questions about the UHC/HI program or have a patient who is in need of services for their online-purchased hearing device or who has questions about their benefit as a subscriber, should contact Jennifer Stalpes, Vice President of Business Strategy and Development for hi HealthInnovations.
The AAA and the ADA will continue to urge consumers who are experiencing hearing problems to use this link as a screening to help them know if they need to seek evaluation and treatment from an audiologist. Further, we will remind consumers that hearing aids are not always the recommended course of treatment for hearing loss. We all know that professional intervention is the critical component that maximizes the treatment outcome for each patient and this in turn results in improved quality of life for the individual. To this end, we will continue to pursue a thorough understanding of the hi HealthInnovations program and its impact on our patients and we will work to ensure that patient care is delivered in a manner that is aligned with best practices. This situation is evolving almost daily and we are working hard to understand the impact on audiologists and the patients we serve. Issues related to licensure, consumer protections, regulatory requirements, professional intervention in the UHC program provided by audiologists, etc., are dynamic. We appreciate your support of these efforts and know that we are interested in hearing about your experiences with this program.
We request that you alert the AAA and the ADA of any actions you take personally or within your state on behalf of patients you encounter who are participating in the UHC hearing device benefit.
United Healthcare (UHC), the largest U.S. insurer by revenue, announced on October 3, 2011, that it will provide subscribers and the general public with online hearing testing and allow the purchase of hearing aids via the Internet through its subsidiary hi HealthInnovations.
This announcement came on the same day that UHC’s parent company, United Health Group, introduced its 2012 Medicare Advantage Plans and began marketing to elderly subscribers. The announcement also ironically coincided with United Health Group’s (United Health Foundation) announcement that it would provide a $50,000 grant to the National Council on Aging (NCOA) so that NCOA can “expand outreach efforts to seniors and aging services organizations, reminding them to work with health care professionals for appropriate (hearing) screening.”
The announcement by United Healthcare to offer an online hearing device benefit for hearing healthcare has prompted growing concerns within the health community:
October 12, 2011: The Better Hearing Institute (BHI) released a press release warning consumers against “Do it Yourself Hearing Care.” Read the full release here.
October 26, 2011: The Minnesota Department of Health released a statement stressing the importance of seeing a hearing health practitioner for hearing loss and advising that failure to do so “skirts state and federal legal protections and could result in harm.” Read the full release here
Note that United Healthcare, UnitedHealth Group, and hi Health Innovations are all based in Minnetonka, Minnesota.
October 26, 2011: An attorney retained by the International Hearing Society (IHS) sent a letter to hi HealthInnovations requesting that the company cease and desist selling hearing aids through its website. Read the full letter here: http://ihsinfo.org/pdf/IHS_Letter_to_HealthInnovations.pdf
October 31, 2011: Following multiple discussions, emails and the AAA October Board meeting, the ADA and the American Academy of Audiology (AAA) collaborated on letters sent to Lisa Tseng, M.D., Chief Executive Officer of hi HealthInnovations and Rhonda Medows, M.D., Chief Medical Officer of United Health Group, expressing concerns and requesting additional information regarding the insurer’s plans for an online hearing device benefit. Read the letters to Dr. Tseng and Dr. Medows
October 31, 2011: The Minnesota Academy of Audiology issued a statement indicating their position on the issue on Internet hearing aid sales. Read more…
November 2, 2011: The AAO-HNS writes a letter to UHC expressing concern about the online testing and delivery of services and “cutting” out the otolaryngologist, audiologist, and other health care professionals.
December, 2011: Important Notice to Ohio Consumers With Hearing Loss, Including Those Who Are Receiving Or Intending To Receive Hearing Aids:
The Ohio Board of Speech-Language Pathology and Audiology (OBSLPA) would like to stress the importance of seeing an audiologist if Ohio consumers have concerns about hearing loss. An audiologist will take a case history, visually inspect, examine, and diagnose for hearing impairments, conduct hearing tests, recommend a hearing aid, or determine if consumers should be seen by a medical specialist.
January 23, 2012: The Florida Academy of Audiology announces to members that the delivery of a hearing aid purchased through UHC is in violation of state licensure law, as is the programming of the device by an audiologist. Audiologists and patients are encouraged to contact the Florida Office of Attorney General with questions and concerns.
February 9, 2012: The AAA and ADA, in collaboration with the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), the International Hearing Society (IHS), and the American Speech-Language-Hearing Association (ASHA) issued a joint position statement on Consumer-Administered Hearing Tests and Direct-to-Consumer Hearing Aid Sales. Please click here to view the statement.
March 28, 2012: hi HealthInnovations receives a cease and desist letter from the U.S. Food and Drug Administration (FDA). The FDA asserts that hi HealthInnovations is in violation of the Federal Food, Drug, and Cosmetic Act, which requires marketing clearance or approval of devices by the FDA. The test is considered a device under the Act as its intended use is diagnostic in nature. The standards set forward in the Act are crafted to ensure patient safety as well as the efficacy of devices. The FDA has deemed hi HealthInnovations’ lack of adherence as a violation. Click here to read the letter.
May 4, 2012: The American Academy of Audiology sends a letter to the FDA commending their action calling for hi HealthInnovations/UHC to discontinue the use of the online hearing aid purchase. Click here to view the letter.
May 4, 2012: The American Academy of Audiology sends a letter to the Centers for Medicare and Medicaid Services (CMS). The letter asserts that United Healthcare/hi HealthInnovations (UHC/HHI) Medicare Advantage hearing aid benefit effectively denies to Medicare Advantage beneficiaries a diagnostic service performed by a qualified health professional under Part B that is currently available to Medicare fee-for-service beneficiaries, thereby creating an inequitable level of service problem that necessitates CMS review. Click here to view the letter.
May 7, 2012: The Texas Academy of Audiology sends notice to audiologists that patients with complaints about hearing devices purchased through UHC/hi HealthInnovations or any other internet site, should lodge them with the State Board of Examiners for Speech-Language Pathology and Audiology:
Complaints Management and Investigative Section
P.O. Box 141369
Austin, Texas 78714-1369
OR call 1-800-942-5540 to request the appropriate form or obtain more information.
This number is for complaints only.
A complaint form and instructions are available here.
May 15, 2012: The Academy, in collaboration with the Academy of Doctors of Audiology (ADA), the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), the International Hearing Society (IHS), and the American Speech-Language-Hearing Association (ASHA), sends a letter to every state department of health in the country asking them to advise consumers who suspect that they have hearing loss to seek a comprehensive hearing evaluation by a licensed hearing healthcare professional prior to purchasing hearing aids over‐the‐counter or through the Internet. Click here to view the letter. Click here to view the joint press release
May 29, 2012: Academy receives response to May 4th letter from CMS stating their intent to monitor the UHC/HHI program and has asked HHI to inform CMS in the event they plan to repost the online test for additional review. Click here to view the letter
August 17, 2012: The Academy, the Academy of Doctors of Audiology (ADA), and the American Speech-Language-Hearing Association (ASHA) send a message to their members outlining steps that audiologists might consider in assisting in the paradigm shift with regard to the direct-to-consumer hearing aid model. Click here to view the message.
August 20, 2012: Academy releases Quick Reference Guide For Audiologists in the Direct-to-Consumer Hearing Aid Model
August 17, 2012: The Texas State Board of Examiners for Speech-Language Pathology and Audiology and the Texas State Committee of Examiners in the Fitting and Dispensing of Hearing Instruments send a letter to UHC/hi HealthInnovations asking them to “immediately CEASE and DESIST from continuing your current business practices as they relate to the fitting and dispensing of hearing instruments in the State of Texas until such time as you and your company can demonstrate to the satisfaction of the Board your ability and intent to comply with our laws.” Click here to view the letter.
September 7, 2012: The Academy sends a letter to the FDA outlining concerns and requesting action regarding the Web site www.thegoodear.com, which offers an online hearing test as well as a sound “therapy” application, which purports to restore hearing loss. View the Academy’s comments here.
December 7, 2012: The Arizona Commission for the Deaf and Hard of Hearing releases a position paper “strongly opposing any delivery model that takes a device-centered rather than person-centered approach.
Other Useful Resources
- Hearing aids are medical devices currently regulated by the U.S. Food and Drug Administration (FDA) and must be recommended, distributed and fit by qualified health professionals.
- American Academy of Audiology and the Consumer website.
- Consumer Reports Hearing Aid Checklist.
- National Institute on Deafness and Other Communication Disorders (NIDCD).
- Hearing Loss Association of America (HLAA) Position Statement on Hearing Aids for People with Hearing Loss.
Click here for previous Academy actions and additional resources
Van Tasell, Diane J., Methods for Prescribing Gain for hi HealthInnovations’ Hearing Devices: Reliability and Accuracy, Hearing Review (January 2012) located at http://www.hearingreview.com/issues/articles/2012-01_02.asp