December 15, 2017
The Honorable David Shulkin
Department of Veterans Affairs
810 Vermont Avenue, NW, Room 1063B
Washington, DC 20420
RE: RIN 2900-AP46, Prosthetic and Rehabilitative Items and Services
Dear Secretary Shulkin:
The American Cochlear Implant Alliance (ACI Alliance) appreciates the opportunity to
submit comments on the Proposed Rule, RIN 2900-AP46; Prosthetic and Rehabilitative
Items and Services published in the Federal Register on October 16, 2017. We are
writing regarding Veterans Affairs services to veterans who have developed
moderate-profound hearing loss as a consequence of noise exposure while
serving our country. One of the major concerns of the ACI Alliance is access to
appropriate care for patients who could benefit from hearing restoration via
ACI Alliance is a non-profit 501(c)3 organization whose mission is to advance the gift of
hearing provided by cochlear implantation (CI) and other implantable prosthetic hearing
implants through research, advocacy and awareness. The membership includes
clinicians who provide the CI intervention (e.g., ENT surgeons, audiologists, speech
language pathologists, other professionals on implant teams including psychologists,
researchers, adult cochlear implant recipients, parents of children with cochlear implants
and other advocates. The organization seeks to ensure appropriate access to, and
quality of, clinical care relating to cochlear implantation. A number of our physicians and
a few audiology members are involved in providing cochlear implant services through
the VA system.
The Proposed Rule reviews the VA role in serving veterans and notes that the “promote,
preserve, or restore” criteria are not specific enough to properly articulate the concept of
medical necessity. There is discussion of clarifying current practices and proposed
needed changes. There is very brief mention of the need to furnish veterans with
services to overcome a disability, including those who are blind or deaf. There is mention
of “implant” on page 48023 and that the VA provides implants as part of the prosthetics
program though no specific mention is made of cochlear implants. We are puzzled by
the absence of specificity related to the appropriate management of advanced hearing
loss as a consequence of military service. Nonetheless we are aware of the VA’s
commitment to hearing healthcare and were repeatedly told by veterans that they
received excellent and supportive services at the VA.
Deployment to a war zone increases the risk of hearing loss, with 71% of soldiers
returning from Iraq or Afghanistan reporting exposure to loud noise
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4918647/. Some estimates indicate that
one in three solders returning from a war zone have measurable hearing loss, which can
worsen over time. In 2014, more than 933,000 veterans received disability compensation
for hearing loss and nearly 1.3 million received compensation for tinnitus.
Cochlear Implants and Hearing Restoration
A cochlear implant is an electronic medical device that restores the ability to perceive
sounds and understand speech by individuals with moderate to profound hearing loss
who are not sufficiently helped by hearing aids. Unlike a hearing aid, which delivers
amplified sound acoustically, a cochlear implant bypasses damaged hair cells in the
cochlea and stimulates the remaining nerve fibers directly through the application of
electrical current. While hearing aids help the majority of individuals with hearing loss by
amplifying sound, even the most advanced hearing aids may not overcome the hearing
difficulties associated with moderate to profound hearing impairment. Noise exposure,
the reason for most veterans’ hearing loss, can cause someone to lose their ability to
understand speech in quiet or in noise and in a range of settings. For veterans leaving
military service and entering the workforce, a significant hearing loss can add further to
the challenges of adjusting to civilian life. Veterans who had normal or nearly normal
hearing before entering military service typically respond well to the sound provided by
cochlear implants. A common response by someone who has undergone cochlear
implantation is “I got my life back.”
Veterans Affairs and Cochlear Implants
Cochlear implantation is provided to veterans with service-related hearing loss who meet
VA criteria through Veterans Affairs. The VA is diligent about selection of experienced,
highly skilled clinicians to perform the surgery and needed audiology follow-up.
Veterans who have received CIs through the VA system are complimentary of the
services. There are some issues with the limited number of implanting centers, which in
some areas of the country can pose challenges for veterans who have difficulty traveling
to distant sites. In 2016, there were 33 VA medical centers that performed the surgery
with approximately half that number providing “programming only.” A total of 477
individuals received cochlear implants in the VA system in 2016 compared with 757,477
hearing aids dispensed in the same year. (Source for statistics: JDVAC National
Program Update, Anaheim, CA, 2/2017).
Utilization of cochlear implants in the general adult population remains low due to a lack
of awareness about candidacy and outcomes; this issue is not unique to the VA. At the
same time, the penetration among eligible adults at 6-10% (Source: Sorkin DL, Cochlear
implantation in the world’s largest medical device market: Utilization and awareness of
cochlear implants in the United States, Cochlear Implants International, V14 S1, March
2013) is still considerably higher (by a factor of 100) than that for veterans receiving
hearing services in the VA system.
2016 VA/US Hearing Technology Utilization
|Est adults fit with HA's
|Est CI adults candidates (5% of HA users)
|Est adults implanted with CI
|Ratio (%) CI/HA
References for above:
If it is assumed that each hearing aid dispensed by the VA involves a bilateral fitting, a
total of 378,723 individuals were fit with amplification in the VA system in 2016. At least
5% of hearing aid users are candidates for a cochlear implant. Using this as a
conservative estimate, this translates to 18,936 veterans who were CI candidates in
2016 (compared with the 477 who actually received a cochlear implant in that year).
Expressed as a percentage, only 1/10 of 1% of veterans who received hearing aid
services in the VA system and who could be assumed to be CI candidates actually
received them—compared with 10% who received CI outside of the VA system. This is a
significant disparity for veterans being served within the VA system.
There are serious heath care effects that may occur as a consequence of undertreating
hearing loss including depression and increased incidence and severity of dementia in
older adults—health effects that have been documented in a large body of research.
Candidacy and Referrals
In most instances when someone is being served within the VA system, they remain in
that system and do not seek a second opinion elsewhere. Some veterans do educate
themselves and go outside the system for additional information especially when they
meet individuals with cochlear implants who are performing so much better than they are
with hearing aids. Clinicians who have encountered such individuals report that it
appears that many audiologists in the VA system tend to retain veterans in the system
without providing information about an individual’s possible CI candidacy. Most VA
audiologists are trained to fit hearing aids and provide assistive devices but many are
unfamiliar with 2017 CI candidacy and outcomes. There have been many changes in
candidacy and testing, given improvements in the technology and the potential to greatly
enhance performance over hearing aids.
Cochlear implant clinicians outside of the VA system have reported seeing veterans who
were not counseled about their CI candidacy because of age or the type of hearing loss
they had (i.e., Meniere’s Disease) or for other reasons. Neither age nor Meniere’s is a
contraindication for CI. Some VA audiologists determined that an individual was “getting
by” with hearing aids even though cochlear implantation would have likely made a
dramatic difference in the person’s communication abilities and quality of life. Veterans
should not need to go outside the VA system to receive appropriate counseling on CI
candidacy and outcomes. Since many veterans rely upon hearing healthcare from VA
audiologists, veterans are not uniformly receiving appropriate information so that they
may make informed decisions about whether to pursue cochlear implantation—either in
or outside of the VA system.
Determining candidacy for cochlear implantation is more complicated than a hearing aid
evaluation. VA audiologists indicate that they are testing patients in quiet, a protocol that
is inconsistent with what the majority of experienced CI audiologists are using for adult
candidacy determination in 2017. CI technology has evolved dramatically in the past 10
years, providing better outcomes in noise and in quiet as well as ease of connection to
other technologies like Bluetooth or direct connect with cell phones. Given the need for
people to move through their lives and be able to communicate in quiet or noisy
environments, most CI audiologists now test patients in best-aided condition in noise.
This was confirmed by a recent study, which queried CI audiologists: “What speech
recognition measures do you typically use to determine candidacy for a cochlear
implant?” The possible answers were:
- CNC words
- AzBio Sentences in +10 S/N
- AzBio Sentences in +5 S/N
- AzBio Sentences in quiet
- HINT Sentences
- Depends (please explain):
- Other (please explain)
A majority of audiologists (31/39) reported that they test in either a +5 or +10 S/N
ratio. Many said that the noise level depends on how well the patient does in quiet.
Seven of thirty-nine reported that they test only using measures in quiet. One audiologist
(of the 39 respondents) said that she only sees pediatric patients. (Source: Dunn, CC,
2017 Best Practice for the CI Patient with Residual Hearing. Presented at an NYU
sponsored conference Maximizing Performance in CI Recipients: Programming
Concepts. NY, NY, 12/2017.)
There is a large and growing body of literature demonstrating the benefit of candidacy
testing in noise. A study of patients meeting Medicare candidacy found that testing in
noise identifies those older adults who are having great difficulty in noise but not
necessarily in quiet. The study also found that CI improved hearing in both quiet and
noise (Source: Mudery JA et al, Older individuals meting Medicare cochlear implant
candidacy criteria in noise but not in quiet: are these patients improved by surgery?
Otology & Neurotology, 38:187-191, 2016). Given that many VA patients are over the
age of 65, this is an especially relevant finding.
American Cochlear Implant Alliance members recognize the VA’s excellence of hearing
health care. However, we feel that there is inconsistency in the way that CI candidacy is
determined and also in the manner in which veterans receive information about their
possible CI candidacy. Veterans with hearing loss receiving hearing services from the
VA are typically cared for by hearing aid audiologists. Such clinicians may have a narrow
and outdated view of who may be a candidate. There is a need for training and updates
on current candidacy practices and outcomes so that the VA can be better aligned with
what is considered best practice today.
Thank you for the opportunity to comment on the topic of prosthetics and rehabilitative
services in the VA System.
Donna L. Sorkin
American Cochlear Implant Alliance
www.acialliance.org / 703.534.6146
One Page Summary
Click HERE for a print friendly version of this summary.
Veterans Administration Practices Relative to Cochlear Implantation
ACI Alliance members include clinicians who provide cochlear implant services in a range of settings including the VA system.
Although the VA is diligent about selection of experienced, highly skilled clinicians to perform the surgery and needed audiology follow-up, the VA lags behind other providers in offering and referring candidates for cochlear implantation.
- Deployment to a war zone increases risk of hearing loss, with 1 in 3 returning with measurable hearing loss, which can worsen over time.
- In 2014, more than 933,000 veterans received disability compensation for hearing loss.
- In 2016, a total of 477 individuals received cochlear implants in the VA system compared with 757,477 hearing aids dispensed in the same year.
- Most VA audiologists are trained to fit hearing aids and provide assistive devices, but many are unfamiliar with current CI candidacy testing and outcomes.
- Cochlear implant clinicians outside of the VA system have reported seeing veterans who were not counseled about their CI candidacy because of age or the type of hearing loss they had—neither are valid reasons for not referring.
- Utilization of cochlear implants by individuals receiving hearing services in the VA system in 2016 was less than that for those in the general hearing health system by a factor of one-fourth. This was computed using a conservative 5% estimate of those using hearing aids as CI candidates.
- ACI Alliance ask: Congressional guidance to VA to: (1) utilize contemporary CI candidacy methodology and (2) conduct staff training to align the VA with current practices regarding cochlear implantation.
Supporting Data: VA vs General Hearing Health System
|Est adults fit with HA's
|Est CI adults candidates (5% of HA users)
|Est adults implanted with CI
|Ratio (%) CI/HA
© 2018 American Cochlear Implant Alliance