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Tuesday, November 17, 2015

By Alissa Katz


Those who use hearing aids have relatively the same cognitive level compared with those with no hearing loss, according to a new study published in Journal of the American Geriatrics Society. (


The researchers, led by Hélène Amieva, a professor at the University of Bordeaux, France, followed 3,670 adults 65 and older over a 25-year period. They compared the trajectory of cognitive decline among older adults who were using hearing aids and those who were not, and found no difference in the rate of cognitive decline between a control group of people with no reported hearing loss and people with hearing loss who used hearing aids.


Hearing loss, however, was significantly associated with lower baseline scores on the Mini-Mental State Examination (MMSE) (β = -0.69, P <.001) and greater decline during the 25-year follow-up period (β = -0.04, P =.01) independent of age, sex, and education. Alternatively, subjects with hearing loss using a hearing aid had no difference in cognitive decline (β = 0.07, P =.08) from controls. The study doesn’t specifically document that hearing loss has a direct effect on cognitive decline, but it concludes that the mental and social consequences of a hearing loss probably mediate the relation. Improving hearing ability by using hearing aids or cochlear implants therefore reduces the negative mental effects of hearing loss and increases the ability to participate in mentally stimulating activities, thereby slowing cognitive decline.

Monday, August 24, 2015

By Alissa Katz


The Academy of Doctors of Audiology (ADA) has formally requested a rescission of the approval for the International Hearing Society (IHS)’s National Guidelines for Apprenticeship Standards for hearing aid specialists. The program was certified by the U.S. Department of Labor in June.


“We have been working with counsel over the past several weeks, really since this was introduced, to investigate the legalities of this program as it relates to current state licensure and educational requirements,” said ADA President Kim Cavitt, AuD.


The Hearing Aid Specialist Certified Apprenticeship is a competency-based program designed to take two years and encompass 4,000 hours of training.


“It’s all about bringing more hearing aid specialists, expanding our profession because there are so many people who need to be served,” said IHS President Scott Beall, AuD. “Between audiologists and hearing aid specialists, we just don’t have enough.”


However, the ADA contends that the new effort encroaches on an audiologist’s scope of practice, Dr. Cavitt said.


“If you delve into this apprenticeship program, which we have, this apprenticeship program talks about cerumen removal, interpreting tests of middle ear function, determining candidacy for cochlear implants, rehabilitative and medical intervention, designing and modifying auditory equipment, providing aural rehabilitation, and providing tinnitus management. That is not the dispensing of hearing aids.”


Larry Eng, AuD, president of the American Academy of Audiology (AAA), said the academy had reviewed the press release issued by IHS and commends the society for improving and standardizing education for hearing instrument specialists but also hopes the program isn’t an attempt for hearing aid specialists to broaden their scope of practice.


“The scope of practice for audiologists is much greater and requires a foundation in the anatomy and physiology of the hearing and vestibular system, neuroanatomy, acoustics, and psychoacoustics,” Dr. Eng said.


In an interview with The Hearing Journal before ADA’s official announcement of the rescission request, Dr. Beall said the apprenticeship program will not change a hearing aid specialist’s scope of practice. HJ emailed Dr. Beall after the announcement but has not gotten a further response yet.


“We are a subset of the broad range of competencies in audiology,” Dr. Beall said in the original interview. “We’re not looking to expand our scope of practice to encroach upon anything audiologists do that only audiologists can do.”


Dr. Cavitt said she was disappointed to hear this viewpoint from the International Hearing Society. 


“I do not believe that any of the training programs that have been developed to date are equal to a bachelor’s degree and a three- or four-year doctoral program with 1,820 hours of clinical education. It’s just not commensurate.


“I firmly support their ability and their right to dispense hearing aids and to test hearing for the sole purpose of dispensing hearing aids. I do not believe they have any rights beyond that.”

Wednesday, May 27, 2015

By Alissa Katz


Photo credit: © iStock/mjunsworth


On May 21, U.S. Reps. Lynn Jenkins (R-KS) and Matt Cartwright (D-PA) reintroduced the Audiology Patient Choice Act (H.R. 2519), which would add audiologists to the list of physicians recognized by Medicare and eliminate the physician order requirement for audiological evaluations.


The bill, originally introduced July 31, 2014, came out of the Academy of Doctors of Audiology (ADA)’s 18x18 initiative, which calls for the amendment of Title XVIII of the Social Security Act by 2018 to allow for the changes included in the legislation.


H.R. 2519 won’t expand or add services to the Medicare program or modify an audiologist’s scope of practice, but it would authorize Medicare to reimburse audiologists for currently covered services that they are already licensed to provide. The legislation also won’t affect state licensure requirements for audiology practice.


“Medicare really has not kept pace with best practices for the delivery of hearing and balance care,” said Eric Hagberg, AuD, ADA advocacy chair, in an interview with The Hearing Journal (HJ) when Reps. Jenkins and Cartwright first introduced the bill (HJ October 2014 issue, p. 8).  


“The healthcare delivery models of the future are being designed to ensure that every practitioner is working to his or her full scope of practice. It's so important that we do this so we achieve patient-centered care that is also cost-effective.”


The American Academy of Otolaryngology–Head & Neck Surgery (AAO–HNS) opposed the legislation when it was initially introduced, and the American Speech–Language–Hearing Association (ASHA) did not endorse it.


The Audiology Patient Choice Act has received endorsements from about 30 other state and national organizations representing audiologists and patients, including the American Academy of Audiology (AAA).


The AAA also is committed to the Access to Hearing Healthcare Act (H.R. 4035, S. 2046), which was introduced in February 2014 and would eliminate the physician order requirement for Medicare patients seeing an audiologist. This bill was endorsed by the ADA as well.


“We believe that the reciprocal endorsement of our respective legislative initiatives sends a strong message to our memberships, the audiology community at large, and members of Congress that the two associations have analogous objectives,” AAA President Erin Miller, AuD, previously told HJ (HJ January 2015 issue, p. 34).

Thursday, November 06, 2014

By Alissa Katz



The Centers for Medicare & Medicaid Services (CMS) will continue to cover auditory osseointegrated implants (AOIs) as a Medicare benefit, the agency announced, retreating from its previous proposal to classify the devices as hearing aids, which are excluded from Medicare coverage.


We believe AOIs that provide focused stimulation to the temporal bone structures, through an implant that is physically integrated into the bone of the skull, to the cochlea are outside the scope of the hearing aid exclusion,” CMS said in a final rule released Oct. 31.


Osseointegrated implants have been payable by Medicare as prosthetic devices that replace the function of the middle ear since Jan. 1, 2006. From that time on, 40,000 people have been implanted in the United States, with 20 percent of these procedures covered by Medicare, according to the Hearing Industries Association (HIA).


Given the device’s history of coverage, safety, and efficacy for a patient population with no auditory alternative, the hearing healthcare community was surprised and concerned by the CMS proposal published in July, which asserted that osseointegrated implants such as bone-anchored hearing devices are bone-conduction hearing aids that mechanically stimulate the cochlea and, as such, should be classified under the hearing aid exclusion.


“CMS felt that the implanted device did the same function as a bone-conduction hearing aid because they both transmit sound via bone conduction,” said Lisa Satterfield, MS, director of healthcare regulatory advocacy for the American Speech–Language–Hearing Association (ASHA).


“But they were failing to realize the benefits of having it implanted into the mastoid process, which include better attenuation and better sound quality, and the device doesn’t need to include amplification like a hearing aid would.”


Lisa Satterfield, MS


The proposal not only would have restricted access to auditory osseointegrated implants among future Medicare recipients who need them, such as those who have single-sided deafness or are not able to wear a hearing aid because of congenital conditions like microtia or atresia, but also likely would have affected patients with private insurance, as these payers usually take their cue from CMS. Hearing healthcare professionals were also concerned that such a policy change would have put maintenance and upgrades out of reach for current implant recipients.


In response to the proposal, providers, patients, and members of industry joined to raise awareness and encourage others to voice their support for maintaining coverage of these devices.


Cochlear Americas posted a petition on to continue coverage of its Cochlear Baha Implant System, and representatives from the Academy of Doctors of Audiology, the American Academy of Audiology, the American Academy of Otolaryngology–Head and Neck Surgery, ASHA, HIA, and consumer organizations met with CMS to discuss why they objected to the proposal and how its adoption would affect patients.  


CMS ultimately received about 2,635 public comments on the proposal that argued these major points:


  • An auditory osseointegrated implant is a prosthetic device that replaces all or part of an internal organ.


  • An AOI is not a hearing aid; it replaces the function of the outer and middle ear.


  • When the device is surgically placed, is becomes part of the patient’s skull anatomy.


  • Candidates for AOI devices typically have no other reasonable option for hearing assistance or restoration, and they do not benefit from hearing aids.


  • Auditory osseointegrated implants have made a profound difference for people with hearing loss, significantly improving their quality of life.


These comments and the efforts of the hearing healthcare community worked, with CMS deciding not to withdraw coverage.


“Cochlear devices, brainstem implants, and AOIs are invasive devices and are significantly different than the hearing devices in existence at the time the Medicare coverage exclusion for hearing aids was enacted,” CMS said in the final rule. “We therefore do not consider them to be the hearing aids or technological refinements of the hearing aids excluded from the program in 1965 and after 1965.”


The hearing healthcare community has applauded the final decision.


“We were thrilled to work with our congressional hearing health champions as they urged CMS not to pull coverage for devices and procedures that had been covered for eight years with good reason,” said HIA Executive Director Andy Bopp.


Andy Bopp


“We’re thrilled to see that CMS gave it another look and, in our opinion, did the right thing.”

Thursday, August 28, 2014

By Alissa Katz




Nearly a decade after approving coverage for auditory osseointegrated implants, the Centers for Medicare & Medicaid Services (CMS) proposed a reversal that would classify the devices as hearing aids, making them ineligible for Medicare coverage.


“The announcement came as a surprise to many of us,” said John Niparko, MD, professor and chair of the Department of Otolaryngology–Head & Neck Surgery at the Keck School of Medicine of the University of Southern California. “We had felt that the support of this technology by CMS was providing a critical opportunity for a small subpopulation of patients who require this approach in order to restore hearing.”  


John Niparko, MD


Under current regulations, which have been in place since Jan. 1, 2006, osseointegrated implants are payable by Medicare as prosthetic devices that replace the function of the middle ear.


According to the new proposal published July 11, however, the agency reevaluated the scope of Medicare’s hearing aid coverage exclusion after getting requests to consider additional implanted and non-implanted auditory devices as prosthetic devices, and came to this conclusion:


“The hearing aid exclusion encompasses all types of air-conduction and bone-conduction hearing aids (external, internal, or implanted). Osseointegrated devices such as the BAHA [bone-anchored hearing aid] are bone-conduction hearing aids that mechanically stimulate the cochlea; therefore, we believe that the hearing aid exclusion applies to these devices and propose that Medicare should not cover these devices…”


Because osseointegrated implants are surgically inserted, it “defies common sense” to call them hearing aids, said Andy Bopp, executive director of the Hearing Industries Association.


“It does replace a body part—a human function—and it’s placed by a doctor.”


Andy Bopp


The American Academy of Audiology (AAA) also disagrees with the proposal, said AAA president Erin Miller, AuD, and that position is shared across the hearing healthcare community, from providers and manufacturers to patients.


“The osseointegrated implant is a prosthetic device,” Dr. Miller said, speaking on behalf of the Academy. “It actually does replace the function of the middle ear, and it should continue to be covered.” 


Erin Miller, AuD


CMS’s proposal does not affect brainstem and cochlear implants, which would continue to be covered as devices that directly stimulate the auditory nerve, replacing the function of the inner ear.




A bone-anchored hearing device was first implanted in 1977 in Sweden and received U.S. Food and Drug Administration approval in 1996.


“This isn’t a new intervention,” Dr. Miller said. “It has a proven track record.


“The current regulation prohibits people from providing this particular device unless it’s the only device option available to the patient. These are patients who couldn’t receive benefit from any air-conduction and/or other bone-conduction device.


“There would be a population of patients who would not receive the services they need to communicate effectively, so it’s very concerning for the consumers whom we treat.”


Candidates for osseointegrated implants, such as Cochlear’s Baha Implant System and Oticon Medical’s Ponto Bone Anchored Hearing System, may not be able to wear a hearing aid because of congenital conditions like microtia or atresia. In patients with single-sided deafness, osseointegrated devices pick up sounds from the deaf side and send them through the bone to the hearing ear.


Currently, Medicare pays for Cochlear’s osseointegrated devices in a bundled payment that covers the cost of the device and operating room time, said a Cochlear Americas representative.


The national average bundled rate for hospital outpatient treatment is $9,732, and the national average for an ambulatory surgical center is $7,987. Medicare beneficiaries typically are responsible for a deductible and coinsurance for each service provided, the Cochlear representative added.


According to CMS, the proposal “would not have a significant fiscal impact on the Medicare program because the Medicare program expenditure for BAHA paid under Medicare during the period CY [calendar year] 2005 through CY 2013 was less than 9,000,000 per year.”


If approved, however, CMS’s classification of osseointegrated implants as hearing aids would likely affect more than Medicare patients, said Shannon Weinberg, senior manager of marketing strategy for Cochlear Americas.


“Private payers typically follow the lead of CMS, so they really are setting the tone across the industry.”


In general, a bone-anchored implant surgery costs a patient who does not have insurance coverage for the procedure $15 thousand to $25 thousand, said Alan Raffauf, vice president of marketing for Oticon Medical.


Hearing healthcare providers and patients also have raised concerns about how withdrawal of coverage would affect people who already have an osseointegrated device.


“I would be up a creek if I were not able to continue advancing in the technology,” said Dan Nettler, who was diagnosed with single-sided deafness in 1971 and received his first osseointegrated hearing device in 2005. Mr. Nettler is a Cochlear volunteer speaking from his own experience, he noted.


“I would not be able to afford out-of-pocket coverage for this type of device. I would have to constantly seek some sort of repair and, hopefully, not return one day to having single-sided deafness. That scares me more than you could imagine.”


Dan Nettler




The hearing healthcare community has been raising awareness about the CMS proposal and encouraging providers and patients alike to show their support for continued coverage of osseointegrated devices.


Cochlear Americas posted a petition to that effect on Additionally, representatives from the Academy of Doctors of Audiology, the American Academy of Audiology, the American Speech–Language–Hearing Association, and consumer organizations met with CMS Aug. 5.


“It didn’t go as well as I’d originally hoped it would,” said Lisa Satterfield, MS, the director of healthcare regulatory advocacy for ASHA, speaking on behalf of the association. “We set up our argument to prove that the osseointegrated implant was a prosthetic device because it replaces the function of the outer and middle ear.


“We haven’t changed their minds with those arguments. They feel that the device is a hearing aid because it conducts sound mechanically and not electronically like a cochlear implant.”


Lisa Satterfield, MS


However, the meeting was not the be-all and end-all, Mr. Bopp said, and there’s still more to do.


CMS is accepting comments on the proposal through Sept. 2. The feedback submitted as of late-August disapproved of the proposed change.


“I have not heard any argument from outside of CMS in support of this rule change,” Dr. Niparko said. “There’s a patient population who depends solely on this technology for connectivity to the hearing world, and I think it would be a really, really unfortunate situation if CMS were to change its position and withdraw support for this particular technology."