A cochlear implant is a surgically implanted electronic medical device that enables the restoration of sound awareness and speech recognition in patients with sensorineural hearing loss. Typically, this intervention is pursued for those with hearing loss who do not gain adequate benefit from hearing aids alone. 
     Traditionally, hearing aids are a recommended treatment for mild to moderate sensorineural hearing loss, as hearing aids are able to present a louder or amplified signal to the hearing nerve. However, for people with more severe hearing loss, hearing aid amplification may not be enough. When hearing aids are no longer able to provide sufficient speech clarity, a cochlear implant is an alternative that may be recommended. 
     In a normal hearing pathway, sound is received by the brain via inner hair cells that reside in the cochlea and directly stimulate the hearing nerve. The hearing nerve then sends a signal about the sound to the brain. In people with sensorineural hearing loss, a deficit exists within the cochlea that impairs and distorts the signal that gets sent to the brain, and as the hearing loss becomes more severe, the more distorted and inaccurate the signal becomes. A cochlear implant can electrically stimulate the hearing nerve in place of the damaged hair cells in the cochlea and allow for a more accurate signal to be sent to the brain. This in turn offers the promise of improved speech clarity in addition to improve sound audibility.
      On September 26, 2022, the Centers for Medicare & Medicaid Services (CMS) broadcasted a historic memo announcing that they were expanding the candidacy criteria for cochlear implantation. This decision will allow Medicare’s cochlear implantation eligibility criteria to align more closely with typical private insurance plans for cochlear implantation. Since then, questions have arisen as to who is now an eligible candidate under the new criteria. Furthermore, the Food and Drug Administration (FDA) recently expanded their indications for cochlear implantation to include patients with single-sided deafness. The purpose of this article is to describe these updated Medicare candidacy criteria and FDA label indications for cochlear implantation to help you determine whether you may potentially qualify for this type of hearing intervention.
       Previously, Medicare criteria for cochlear implantation only included patients with severe to profound sensorineural hearing loss who score less than 40% on open-set sentence recognition in their best-aided listening condition. With the expanded Medicare criteria, this requirement is being broadened, and patients with moderate to profound bilateral sensorineural hearing loss who demonstrate limited benefit with binaural amplification are now candidates. Limited benefit from amplification is defined as “test scores of less than or equal to 60% correct in the best-aided listening condition on recorded tests of open-set sentence cognition.” It is expected that this additional 20% margin of allowed performance benefit will significantly increase the number of patients with hearing loss who will qualify for Medicare coverage for this form of hearing intervention. In that regard, this is a historic coverage change that promises to help millions of people with hearing loss have access to cochlear implant technology for the first time.
       The Food and Drug Administration (FDA) label indications for cochlear implantation are also undergoing changes and expansions. FDA label indications are separate guidelines published by the FDA, and historically, these label indications have governed cochlear implant manufacturers and dictated candidacy criteria for many private pay insurances. Most recently, the FDA expanded cochlear implantation label indications to include patients with single-sided deafness (SSD) and asymmetric sensorineural hearing loss for two of the three implant manufacturers. With single-sided deafness, the cochlear implant candidacy conversation with patients is very different. For patients with bilateral sensorineural hearing loss, the main concerns may include understanding speech in one-on-one conversations in quiet; safety and sound awareness; and maintaining the ability to work. For patients with unilateral or asymmetrical hearing loss, the communication challenges are much different and may only pertain to situations where having two ears is required. These include sound awareness on the poorer hearing ear side, localizing sounds in the environment (i.e., knowing where a sound is coming from), and listening in background noise. Patients may also benefit from a cochlear implant if they have significant tinnitus in the poorer hearing ear. 
      Medicare guidelines have traditionally followed FDA label indications but tend to be stricter. Changes made to FDA label indications may precede Medicare guidelines by a few years. This means you can have SSD or asymmetrical hearing loss and be a candidate according to the FDA, but if you have Medicare, your insurance may not approve you as a candidate. 
    If you have already had a cochlear implant evaluation in the past and you weren’t a candidate then, it may be worth revisiting this discussion with your audiologist based on these criteria expansions. Your audiologist can retest you to see if your candidacy status has changed. Furthermore, if you have never been offered this option before but you think that you may fall into these new criteria ranges, you should bring this up with your audiologist or otorhinolaryngologist. Lastly, you may not feel ready for a cochlear implant at this time, and that is okay, too! Some patients are not interested or able to undergo cochlear implantation for physical, mental, or emotional reasons, but having the information is important in case you are ever ready to engage in this discussion. 

Hannah S. Kaufman, AuD, CCC-A
Audiologist III
Coordinator, Implantable Hearing Devices Program

Breanna Corle, BS
Audiology Doctoral Extern
 
Department of Otorhinolaryngology-Head and Neck Surgery
Division of Audiology
University of Pennsylvania Health Systems

 

 

   About Auracast
 

     There has been a good deal of discussion about new technology that might eventually replace loop systems for hearing assistance.  James Rowe, CEO of OTOJOY, a firm specializing in loop system installation, shares this perspective about both forms of hearing assistance:
     Bluetooth is the name given to a standardized protocol for sending and receiving data via a 2.4GHz wireless link. It was first launched in 1999 and that protocol was known as Bluetooth 1.0. Since 1999 there have been 5 major revisions to the protocol, with the most recent in 2016. The most recent version of the protocol is known as Bluetooth 5.0. If you own a smartphone that was released in 2016 or later, you very likely have Bluetooth 5.0 in that product. Likewise, if you own a CI or a hearing aid that was purchased since 2016, you will also likely have Bluetooth 5.0 inside. If you bought your hearing aids in 2014 (for example), then you will have Bluetooth 4.0. If, like my own father, you’re still using a Nokia 3210, then there’s a good chance you have Bluetooth version 1.0! 
       Bluetooth is always evolving, as you can see above, and right up until version 5.0, it was still only a useful protocol to send data between two distinct devices - one sending device and one receiving device: your smartphone (sending device) and your hearing aids (receiving device), for example. Or your smartphone and your car. It is not possible to send data from one Bluetooth device to multiple other devices. 
      That is, until now. Very recently, an update to Bluetooth, which is known as Bluetooth version 5.2, has changed this capability, meaning that for the first time, Bluetooth will be able to be broadcast from one sending device to multiple receiving devices. And that functionality is what has everyone in the assistive listening industry very interested. In theory, you could have one sending device in a church, for example, broadcasting to multiple receiving devices (everyone wearing a hearing aid). 
      Auracast is simply the brand name that the Bluetooth SIG group has given this new broadcast feature. It is NOT a separate Bluetooth release. It is NOT the name given to a specific piece of hardware. It is simply the brand name for the new broadcasting capabilities of Bluetooth version 5.2. 
      Here’s what’s really important to know, though. The Auracast feature will only work if you have a Bluetooth version 5.2 sending device and a Bluetooth version 5.2 receiving device. As of today, there are NO transmitting devices in the market. Companies are working on them, but NONE are available. Added to this, there are almost NO receiving devices in the market. Those that have been released (the newest version of Apple AirPods, for example) DO have the new 5.2 protocol inside, and Apple is saying that when Auracast transmitters are available, it will be a simple software upgrade to turn on the feature in your AirPods. 
      What this means is that virtually NOBODY has the right Bluetooth protocol in their receiving device, and it will require the purchase of a new device (whether that is a smartphone, hearing aid, or CI) in order to take advantage of the technology--and only once manufacturers release transmitters into the market. And that is another big question--when will the first transmitters be available for sale? The other big question for the assistive listening industry is when will hearing aids and cochlear implants be available with Bluetooth 5.2? Estimates range from 2023-2030, depending on the brand. 
     Then it comes to who will pay for this? Any company that wants to use Bluetooth 5.2 in a sending device will need to purchase the license from Bluetooth to do so. Any individual that wants to use Bluetooth 5.2 in a receiving device (smartphone, hearing aid, AirPods, etc.) will buy that consumer product in exactly the same way as they do today. That brand new product (from sometime in 2023) will contain the right version of Bluetooth (5.2) that will then allow for the Auracast feature. Just as you do not have to pay any fees to use Bluetooth today, I can’t imagine a future where you would need to pay fees for that one specific feature. 
    The other big question, of course, is, even when these sending devices and receiving devices ARE available, how well will that Auracast feature work? Whenever you send data wirelessly, there are lots of different places in the transfer chain where “loss” can occur. And if the data being sent is audio, then any “loss” will result in a horrible listening experience. There is a lot for us still to learn before anybody can recommend Bluetooth as an alternative to hearing loops or even FM as a reliable assistive listening method. 
     In the meantime, the hearing loop is the one single technology, available NOW, and compatible with the most receiving devices, that provides a reliable listening experience in a big public space. Or over a counter. Or at an airport gate. Or in a meeting room. Or in the many other examples of where assistive listening is required. 
   Used by permission.

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     2022  PA Walk4Hearing 
 

     The 2022 PA Walk4Hearing was held on October 16, 2022 at The Navy Yard and the weather gods were watching over us as we had perfect fall weather.  The event was a tremendous success and reminded everyone of how much they missed in-person events the last several years.  The PA Walk was one of 20 walks held throughout the country in 2022 and once again the PA Walk was the largest and raised the most donations.  The PA Walk had 67 teams, approximately 1,000 walkers and raised $130,000.
     Walk4Hearing events are celebrations to focus on hearing health and to connect people to solutions that help them live well with hearing loss.  There were 18 vendors at the Walk where attendees could learn about various products and services for those with varying levels of hearing loss.
     At the Walk, individuals with hearing loss are supported by friends, family and hearing health care professionals. They share experiences and learn about technologies and resources.  The Walk is one of the highlights of my year.  My favorite part of the Walk is seeing all the young children who have hearing loss and how their families and friends come out to support them in their hearing loss journey.  It is a festive and positive event where all generations of people come together to support each other.
     Next year’s walk will be on Sunday October 15th at The Navy Yard. Mark it on your calendar! 
 

-Mike Miles