New hearing aid uses lasers, direct eardrum stimulation

Hearing aids have been around since the very end of the 1800s, but surely none of the first users imaged that the devices would eventually use lasers. On September 29, 2015, the FDA approved a new type of hearing aid for marketing that combines laser pulses and direct eardrum stimulation to amplify sound. The EarLens Contact Hearing Device™ (CHD) has received an indication for use in adults with mild to severe hearing impairment.

How does it work?

This device depends on two different parts working in unison. A tympanic membrane transducer (TMT) is placed on the eardrum (non-surgically) while an audio processor sits on the outer ear. The audio processor is connected to an ear tip containing a laser diode, which is placed into the ear canal. When the behind-the-ear (BTE) processor receives external sound waves, it converts them to low electronic signals that are sent to the ear tip. The signals are converted to pulses of light, which shine onto the TMT’s photodetector. The photodetector converts the light back into electronic signals and then transmits the sound vibrations onto the ear drum.

How is it different?

There are already multiple types of hearing aids. Some sit in the ear (ITE), some in the canal (ITC) and some behind the ear.  Older analog hearing aids simply amplified sounds, and some users struggled with them because all sounds were equally amplified by the device’s microphone. Some of these aids are programmable to hold separate settings for various environments, but they are not as sensitive to sounds as digital aids. Digital aids contain a chip that analyzes sounds based on the environment and user’s degree of hearing loss. The microphone amplifies sounds with an adjustment for volume and pitch, as well as feedback.

The EarLens, by contrast, is custom molded to the eardrum. The sounds are amplified by direct stimulation of the eardrum. The FDA believes that this is a new option for amplifying sounds over many frequencies.

Safety and effectiveness

The EarLens was studied over a four-month period for safety and effectiveness. The trials assessed residual hearing stability, amplification gain, and improved word recognition. Users’ ability to hear sentences in background noise with the device was compared to listening without any amplification. After a month of using the device, the 48 subjects experienced word recognition improvement by about a third. They also experienced a significant functional gain in the high frequency range. A maximum of 68 decibels was gained in the 9000-10,000 Hz range, which the FDA notes is not usually achieved with conventional hearing aids. There were some ear canal abrasions experienced, mainly due to the ear tip or forming the impressions. However, no serious adverse events were reported.

Who pays?

Medicare does not cover routine hearing exams or hearing aids. Part B will cover some diagnostic hearing exams if a doctor order these tests (20 percent of the Medicare-approved amount, along with the Part B deductible). Some Medicare Advantage plans may have some sort of hearing coverage. Only a few private insurance companies cover hearing aids, although three states (Arkansas, New Hampshire, and Rhode Island) require coverage for adults. This can be a problem for patients who suffer hearing loss, as prices can range up to thousands of dollars for one aid.

A House bill was introduced in March 2015 (H.R. 1653) proposing to repeal the Medicare hearing aid exclusion. After it was introduced, the Government Accountability Office (GAO) was instructed to study financial aid programs for hearing aids, as well as related examinations for patients suffering hearing loss.

Highlight on New Jersey: Proposed bill would expand palliative care education

The New Jersey Assembly Health and Senior Services Committee approved legislation that would establish a “Palliative Care and Hospice Care Consumer and Professional Information and Education Program,” within the New Jersey Department of Health and would require state-licensed hospitals and other facilities to provide information about palliative care options to patients facing severe illnesses.  The bill (A-3911), which was sponsored by Nancy Pinkin (D-Middlesex) and Herb Conaway, Jr., M.D. (D-Burlington), is intended to “help improve the quality of life and relieve pain and suffering for patients suffering from serious illnesses.”

As detailed in a statement released by Assembly Democrats, the proposed Palliative Care and Hospice Care Advisory Council would be composed of nine members who would work with the Rutgers Cancer Institute of New Jersey to development the informational program. The law would require every licensed hospital or facility that provides long-term care services in New Jersey to make information about palliative care and hospice care available to individuals with severe illnesses. If a patient is not able to make health care decisions, the information must be provided to an individual who is authorized to make health care decisions on that patient’s behalf.

According to the American Cancer Society, palliative care, which is also known as supportive care, is a rapidly expanding specialized field of knowledge that is appropriate at any stage of any serious illness such as cancer, where an individual is experiencing difficulty managing symptoms.  The Society’s website explains that palliative care is “care for adults and children with serious illness that focuses on relieving suffering and improving quality of life for patients and their families, but is not intended to cure the disease itself.” Additionally such care “provides patients of any age or disease stage with relief from symptoms, pain, and stress, and should be provided along with curative treatment.” In the past, such care was associated with providing comfort when treatment was no longer effective at the end stage of life. However, the Society emphasizes that palliative care can provide relief, and is “appropriate at any age and at any stage in any serious illness.”

As reported by NJSpotlight, the growth of palliative care may have been hindered by its association with hospice care, which is not covered by Medicare unless a patient has a life expectancy of six months and forgoes other treatments. However, proponents of the palliative care bill express hope that it will become more widely accepted through simple education.

Co-sponsor Pinkin has emphasized the need to provide education about palliative care for individuals facing serious illnesses who may not be aware of their options. In a letter stressing the importance of the bill, Pinkin stated, “Unfortunately, nearly eight of 10 respondents of a 2011 survey lacked knowledge of palliative care services.” She added, “It is more than just end-of-life care. It is about alleviating pain and suffering associated with serious illness and thereby empowering patients and families to live their lives. Evidence shows that patients undergoing palliative care for lung cancer lived nearly three months longer than those receiving chemotherapy.”

Pinkin’s claims are supported by the American Cancer Society, which points out studies demonstrating the benefits of palliative care, including that patients who received hospital-based palliative care required less time in intensive care units and had lower rates of hospital readmission. Additionally, studies have also shown that individuals experiencing chronic illnesses had less severe symptoms, such as pain, nausea, shortness of breath, and depression, after receiving palliative care, which leads to a better quality of life. Palliative care may also increase survival rates.




The Secretive Business of Providing Health Care Coverage

As Massachusetts was considered a ground-breaking state in offering universal health care to its residents, so too, is it ground-breaking in health cost transparency. As of October 1, 2014, Massachusetts health insurers are now required to provide price information to consumers through online cost estimator tools that compare the price and out-of-pocket costs of certain health care services, procedures, or hospital admissions.

The Massachusetts Healthcare Cost Containment and Quality Improvement law, which was passed in 2012 (Chapter 224 under the Acts of 2012), allows beneficiaries the opportunity to choose providers and obtain information about medical procedure costs, giving patients advance planning capabilities. The online tools will specifically help consumers with high deductible plans or those who have to pay co-insurance.

This is great news for Massachusetts residents, but what about the rest of us? Cost transparency, or the lack of it, is a nationwide problem.

Case Study

The Miami-Dade school district is self-insured and bears the financial burden of covering its own employees. The district superintendent claimed to know what the district pays for health claims, but after school board meetings in 2013 and 2014 in which board members raised concerns over increasing health costs for teachers, it became clear that the superintendent was still in the dark about how much the district pays to any one hospital or provider for a given service. The district uses Cigna for its employee health benefits.

According to the Kaiser Family Foundation (KFF), the district absorbed an additional 4 percent in health care costs in 2014. Teachers’ salary increases have not been matching up to their premium costs, and their health contributions remain largely the same. The head of the district’s teachers’ union has asked the school district to investigate how the cost savings from consistent teacher pay rates were being applied and what other factors might be contributing to the increasing health premiums.

The union leader’s questions will most likely go unanswered. Although the Miami-Dade school district is subject to Florida’s open records laws, its insurance carrier, Cigna, has refused to share contracted prices. This keeps the district and its employees from making informed, financially wise choices and allows insurers to drive up premiums.

ACA Transparency Efforts

In April 2014, CMS sent letters to the American Medical Association and the Florida Medical Association announcing its intention to release Medicare data in the form of the number and type of health care services that providers delivered and the amounts Medicare paid for those services in 2012. CMS explained that the release of information was in response to recent Freedom of Information Act (FOIA) requests. Provisions under the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) include ACA section 10331, which mandates that the Secretary of HHS create a physician-compare internet website to make information on physician performance available to the public. Another provision, ACA section 10332, allows certain entities to access Medicare claims data in order to review the data and issue performance reports about individual providers.

With an increased focus on transparency, the answer to why Miami-Dade school district employees, or the rest of the nation for that matter, must be kept in the dark about health care costs remains a secret.

Medicare Changes May Leave ALS Patients Without a Voice

As of December 1, 2014, some Medicare beneficiaries with amyotrophic lateral sclerosis (ALS) could lose access to certain technological devices designed to facilitate communication, according to a report from Kaiser Health News. Although ALS awareness reached the national spotlight this summer with a far reaching fundraising campaign known as the “Ice Bucket Challenge,” money and notoriety have not insulated patients with ALS from what could be damaging Medicare changes, which could put limits on the ability of ALS patients to effectively communicate.

Speech Devices

At issue are speech generation devices, which are the devices that many patients with ALS use to communicate with others both at range and up close. In a February, 2014, “Coverage Reminder” posted by CMS, a distinction was drawn indicating that Medicare may change the way it reimburses speech devices. Historically, Medicare has provided reimbursement for two kinds of speech generation devices, those classified as “dedicated devices” and those that are upgradeable or “locking.” According to the ALS Association (ALSA), since 2001, Medicare beneficiaries have been able to purchase what are known as locking devices and receive Medicare reimbursement for the basic functions of the device. Then, if a beneficiary chooses, the beneficiary can pay out-of-pocket, without Medicare reimbursement, to unlock additional functions, like word processing, accounting, or other non-medical functions. The locking devices are to be distinguished with devices that only serve a speech generation function. Medicare has also historically covered these “dedicated devices.” Traditionally, Medicare has covered 80 percent of the cost of basic speech generation devices, without regard as to whether they are dedicated or upgradeable.


The Coverage Reminder appears to upend the traditional reimbursement model and “specifies that in order for a speech generating device (SGD) to be considered for reimbursement under the Durable Medical Equipment (DME) benefit, it must be a “dedicated” device.” According to the KHN report, beneficiaries and patient advocates have read the CMS notice to mean that beneficiaries will no longer be provided the opportunity to upgrade reimbursable devices, even at their own cost. In other words, under the new coverage, Medicare will only cover basic devices that are incapable of upgraded functioning. The results are serious for ALS patients who may lose functionality like the ability to connect to the internet. For some patients, that would mean losing the only available means to communicate with people who are not in their immediate vicinity. In some cases, without access to the internet, patients will be left vulnerable and unable to call for help if the need arises.

Device Cost

The changes are likely due to the increases in technology and cost. KHN reports that a basic speech generation device costs somewhere in the neighborhood of $4000, while upgrades, for things like eye-tracking technology, can bring a device’s cost up to as much as $15,000 or more. According to KHN, Medicare has typically paid for about 3,000 devices each year.


The coverage change follows another change by CMS that alters the way patients come to own devices. According to the ALSA, on April 1, 2014, Medicare changed the way it pays for speech generation devices by eliminating the ability of Medicare beneficiaries to either rent or outright purchase a device. Under the new paradigm, beneficiaries are required to rent a device over a 13-month period before being granted the right to purchase the device. Each month, people with ALS are contacted by a device’s manufacturer to be sure that the device is still needed. Only upon the expiration of the 13-month period do the manufacturer’s questions stop.


Efforts have been made to slow or stop the decision to change speech generation device reimbursement. For example, 200 members of Congress sent a letter to CMS urging the agency to address ALS patients’ concerns about device access. CMS has not yet responded to the congressional request for action. ALS patients are hoping that they can stop the change before it takes effect in December. According to KHN, ALS patients are quick to point out that they are not asking for Medicare to cover any extra device functionality, they just want Medicare to continue to cover the portion of the cost of speech generation devices that the program has always covered.