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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 change.org 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.

  

 

WIDESPREAD RAMIFICATIONS

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

 

 

COMMUNITY COMES TOGETHER

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 change.org. 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."


Thursday, August 28, 2014
By Sven Vanneste, PhD
 

Dr. Vanneste is principal investigator of the Lab for Auditory & Integrative Neuroscience and an associate professor in the School of Behavioral and Brain Sciences at the University of Texas at Dallas.


 

Tinnitus remains a clinical enigma, even though much progress has been made. For example, many different tinnitus treatments are offered, but evidence for their efficacy is scarce, and patient satisfaction is low. These treatments mainly improve patients’ quality of life and reduce, to some extent, the awareness of and reaction to tinnitus, but they do not directly modify the tinnitus sound.


A study by Navzer D. Engineer, Michael P. Kilgard, and colleagues introduced a potentially new type of treatment that tries to modulate the tinnitus sound directly (Nature 2011;470:101-104).


It is believed that many types of tinnitus are caused by the generation of pathological neural brain changes in response to cochlear trauma or nerve damage. However, repeatedly pairing tones with brief pulses of vagus nerve stimulation completely eliminates the behavioral correlates of tinnitus in noise-exposed animals and drives auditory cortex plasticity in a controlled and therapeutic direction.


Based on these results, Dirk De Ridder, MD, PhD, and I set up a first clinical trial (Neuromodulation 2014;17[2]:170-179). Ten tinnitus patients who showed no benefit from previous audiological, drug, or neurostimulation treatments received a stimulation electrode directly on the vagus nerve.


The study showed that it is safe and feasible to translate this technique from animals to humans, as no complications arose specifically from pairing sound with vagus nerve stimulation. Half of the participants demonstrated large decreases in their tinnitus symptoms that lasted two months after the end of the therapy.


 

Photo credit: ©iStock/pictore

 

Unlike the animal study, however, not all patients benefitted from the vagus nerve stimulation paired therapy. It is possible that the clinical efficacy was not as strong because the treatment started late after tinnitus onset or because hearing thresholds are different between the animal and human populations.

 

It is not known whether the stimulation parameters used to activate the human vagus nerve are optimal. Further, most animals in an animal study are genetically closely related, while there might be more genetic variability among humans who present at a tinnitus clinic, leading to a less pronounced effect.  


However, post-hoc analysis of the 10-patient trial also revealed that the participants who did not show significant changes were on medications that might prevent the beneficial effect of the therapy.


It is well-known that drugs can interfere with the acetylcholine and norepinephrine metabolism and release that are important to the promotion of plasticity changes and, therefore, could block the effects of vagus nerve stimulation.

 

Even though certain patients were intractable to all other treatments, the ability to help 60 percent to 80 percent of drug-free patients who have chronic, severe tinnitus seemed sufficient to warrant further studies tailored to drug-free patients.

Hence, a second placebo-controlled, multicenter clinical trial is now being conducted to further explore the potential of vagus nerve stimulation as a causal treatment directly targeting the tinnitus sound, with long-term follow-up. More information about the trial is available at tinnitustrial.com.

 

Time will tell if this approach will bring relief to the millions of tinnitus patients awaiting a solution. Results are expected to be available in the middle of next year.


Thursday, August 28, 2014
By Nina Kraus, PhD, & Samira Anderson, AuD, PhD

Dr. Kraus is professor of auditory neuroscience at Northwestern University, investigating the neurobiology underlying speech and music perception and learning-associated brain plasticity.

 
Dr. Anderson is an alumna of Dr. Kraus’s Auditory Neuroscience Laboratory and assistant professor in the University of Maryland Department of Hearing & Speech Sciences, where she is studying the effects of hearing loss and aging on neural processing in older adults.
 
 

Awareness of auditory processing disorder (APD) among parents and educational professionals is rising, along with the demand for diagnostic and treatment services. Still, few audiologists perform these evaluations themselves or even refer patients with suspected APD to audiologists who do.

 

While many reasons exist for this lack of interest or acceptance of APD as part of the audiology profession, the chief reason is that the tests in the available battery do not have good sensitivity or specificity.

 

But how can a test have good sensitivity or specificity when no gold standard exists? Many of the early APD tests were verified in adults with known lesions. Typically, in children, APD neither is associated with a lesion nor can be verified with neuroimaging or surgery.

 

 

A MATTER OF NEURAL TIMING

APD has similarities with auditory neuropathy spectrum disorder (ANSD). Some people with ANSD have normal audiometric thresholds but trouble understanding speech, especially in background noise.

 

If a person with ANSD reports hearing difficulties but has no testing beyond the audiogram and speech perception in quiet, the diagnosis can be missed. Auditory brainstem response (ABR) testing or electrocochleography (ECochG) is needed to detect the disorder.

 

Similarly, APD can be missed by the typical audiometric evaluation, but, in this case, the standard ABR or ECochG results are usually normal. The click and tone-burst stimuli used in these tests do not pick up subtler timing deficits that may be present in APD.

 

In contrast, the auditory brainstem response to complex sounds (cABR) is a more sensitive measure of neural timing. Children with learning disabilities have delayed peak timing compared with children who are typically developing in the cABR, but not in the click-evoked ABR (Audiol Neurotol 2006;11[4]:233-241).

 

Similarly, children who are poor readers have reduced trial-to-trial response consistency in the cABR compared with children who are good readers, while there are no group differences in their responses to clicks (J Neurosci 2013;33[8]:3500-3504).

 

Because children with APD often have difficulty understanding speech in noise, it might make sense to evaluate their processing of such speech using an objective method free from the language, memory, and attention demands that can complicate behavioral APD testing.

 

We and our coauthors recorded responses to the speech syllable /da/ in quiet and in six-talker babble noise (J Neurosci 2010;30[14]:4922-4926) in children who had good and poor scores on the Hearing in Noise Test (HINT; J Acoust Soc Am 1994;95[2]:1085-1099).

 

The normal effects of noise on the ABR include amplitude reduction and peak timing delays, but these effects may vary in individuals. In this study, we found that children with poor scores on the HINT had greater noise-induced peak timing delays than children with good scores.

 

The delays were found in the consonant-vowel transition peaks—the region of the speech syllable with rapidly changing formants—but not for the peaks in the response region corresponding to the unchanging vowel.

 

 

Top panel: The stimulus waveform of the syllable /da/ (first 80 ms) is temporally aligned so that the onset and peaks match the responses in the bottom two panels. Individual responses are displayed for a 10-year-old boy with a good HINT score in quiet (pink) and noise (red), middle panel, and for a 9-year-old boy with a poor HINT score in quiet (gray) and noise (black), bottom panel. The arrows illustrate the delay in noise peaks seen in the responses of the child with the poor score but not in the child with the good score. Note that the peak delays are seen in the transition region but not for the late peaks in the vowel region.

 

 

Although the children in the study did not have a diagnosis of APD, one can see how the cABR can inform APD assessment. A positive finding of excessive noise degradation or decreased synchrony in the cABR would provide biological evidence of an auditory processing disorder.

 

It should be noted that APD may be associated with other factors related to cognitive or executive function. These factors may influence the cABR through top-down connections from the cortex to the brainstem.

 

Given previous findings showing the benefits of training (Beh Brain Res 2005;156[1]:95-103) and FM system use (Proc Natl Acad Sci U S A 2012;109[41]:16731-16736) in children with abnormal cABRs, the inclusion of this test in the APD battery may assist with management. More work should be done to verify the efficacy of using the cABR when evaluating children with suspected APD. 


Wednesday, July 30, 2014
By Dennis A. Colucci, AuD, MA
 
Dr. Colucci is a clinical and forensic audiologist in private practice in Laguna Hills, CA.
 
With high healthcare costs and a patient’s quality of life at stake, it is important that audiologists recognize benign paroxysmal positional vertigo (BPPV) during the intake process and provide a repositioning procedure or appropriate referral that can save someone’s life.
 
Benign paroxysmal positional vertigo is a mechanical anomaly in which calcium carbonate crystals, called otoconia, detach from the otolithic organs and find their way into the semicircular canals.
 
A variety of causes for BPPV are postulated in the healthcare literature, including reduced bone density, cardiovascular and cerebrovascular disease, head and neck trauma, infection, Ménière’s disease, vitamin D deficiency, space launch, surgical drilling, and migraine, although most cases remain idiopathic.
 
In an eight-year study that evaluated 731 patients 70 years of age and older who were seen in a multidisciplinary dizziness clinic, 27.6 percent of the patients had BPPV (Ear Nose Throat J 2014;93[4-5]:162,164,166-167).
 
Photo credit: © Shutterstock/Image Point Fr
 
 
According to the Centers for Disease Control and Prevention (CDC), one in three adults age 65 and older falls annually, with 20 percent to 30 percent sustaining injuries that prevent them from returning to normal activities and increase their risk for early death.
 
Furthermore, seniors are hospitalized five times more often for falls than for any other cause, and the direct and indirect costs of fall injuries are expected to reach $67.7 billion by 2020.
 
The research on BPPV has yielded a revolution in its treatment, with an 80 percent to 90 percent cure rate. Given the treatable nature of the condition and the financial and health consequences of falls, it is critical that audiologists distinguish and extinguish benign paroxysmal positional vertigo.
 
 
DISTINGUISHING AND DIAGNOSING
The primary diagnosis of BPPV is made from a patient’s medical history: namely, a sudden onset of symptoms in the absence of other complications and true vertigo that resolves in less than a minute when the patient is motionless. The diagnosis is qualified by a bedside examination revealing the presence of nystagmus with a short delay after a change of position.
 
Between bouts, the patient may have some sensation of dizziness, but not vertigo.
 
The most frequent site of lesion is the posterior semicircular canal (80%), with anterior canalolithiasis and horizontal canal involvement occurring five percent and 15 percent of the time, respectively (Acta Otorhinolaryngol Ital 2013;33[4]:254-260).
 
Multifocal variants may occur in combination with other disorders, especially in cranio-cervical trauma. In these cases, a complete balance evaluation is warranted.
 
The Dix-Hallpike maneuver is used to identify benign paroxysmal positional vertigo in the posterior vertical canal during bedside testing. The procedure starts with the patient in the sitting position, head turned 45 degrees, and proceeds with the patient reclining to the supine position, with the head in slight retroflexion at 20 degrees.
 
In anterior vertical canal BPPV, symptoms are often worse when the patient moves from the sitting position to the supine position without head turning. For the diagnosis of horizontal canal BPPV, a simple supine head roll test is used, with the patient’s head starting at the center and turning to the right, pausing, returning to the center, pausing, and then repeating on the left.
 
 
EXTINGUISHING BPPV
Benign paroxysmal positional vertigo usually can be extinguished during a single visit. For the common posterior canal BPPV, a simple protocol known as the Epley maneuver is most effective. The maneuver is also used for anterior canal BPPV, with some variation.
 
For the small population in which posterior canal BPPV is not easily resolved, the patient is instructed to do Brandt-Daroff exercises a few times a day, with results seen in 10 days.
 
For horizontal BPPV, maneuvers by Lempert (barbecue roll) and Gufoni are highly effective.
The bedside tests and extinguishing procedures are shown on the American Academy of Neurology YouTube channel.
 
Every audiologist should ask patients about balance, know how to diagnose posterior canal BPPV and other variants, and extinguish the condition or guide patients to balance clinics that specialize in treating this debilitating disorder.
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