OTC

Question 1

Chien & Lin (2012)

Answer 1

Currently, only about 14% of people with HL use a hearing aid

Question 2

Blustein & Weinstein (2016) #1

Answer 2

OTC model can foster competition in the hearing aid market, broaden consumer choice- Vigorous competition might spur the development of more appealing, less prosthetic-looking devices-an innovation that has largely eluded the hearing aid industry to date

Question 3

President’s Council of Advisors on Science and Technology (2015)

Answer 3

Identified cost as the key barrier to ownership and linked high cost to two interrelated institutional factors: (1) the noncompetitive hearing aid market & (2) inefficient hearing aid distribution channels

Question 4

Bainbridge & Ramachandran (2014)

Answer 4

Ownership of hearing aids is lowest among socioeconomically disadvantaged groups, including minorities and those with the lowest income and education

Question 5

Blustein & Weinstein (2016) #2

Answer 5

o Without Medicare or most other insurance plans covering hearing aids, consumers typically pay for aids and fittings out of pocket, and a pair of aids up to $8,000, a sum beyond the reach of many seniors

Question 6

Fischer & Cruickshanks (2011)

Answer 6

o In a recent population-based prospective study, a majority of participants cited cost as a major deterrent to buying a hearing aid

Question 7

Dalton, Cruickshanks, & Klein (2003); Mick, Kawachi, & Lin (2014); Mener, Betz, Genther (2013)

Answer 7

” Ultimately, age-related hearing loss reduces quality of life and is associated with social isolation and depression

Question 8

Davis et al. (2007) #1

Answer 8

” Typically, people wait close to 10 years from the time that they notice hearing loss to the time that they acquire an aid, and by this time, their loss has often progressed to a moderate to severe level

Question 9

Blustein & Weinstein (2016) #3

Answer 9

” Hearing loss can be caused by underlying medical conditions such as acoustic neuroma (tumor of the hearing nerve), chronic otitis media, or impacted ear wax

Question 10

Davis et al. (2007) #2

Answer 10

” In the United Kingdom, for instance, aids are provided by the National Health Service, but uptake and use are not substantially higher there than are uptake and use reported in the United States

Question 11

Wallhagan (2010)

Answer 11

” Stigma profoundly influences acceptance of hearing loss, readiness to have hearing tested, and the decision to use an aid

Question 12

Blustein & Weinstein (2016) #4

Answer 12

” Likewise, many people who own hearing aids do not use them, perhaps because of the incorrect expectation that hearing aids will restore hearing or communication to normal levels

Question 13

Callaway and Punch (2008)

Answer 13

” Used electroacoustic analysis to evaluate eight OTC hearing devices that were priced at a “low-range” which they identified as costing less than $100.
o All of the eight “low-range” devices had a low-frequency emphasis of output.
o Additionally, the low-range devices also had high equivalent input noise levels and potentially posed a residual hearing safety hazard.
o Ultimately, the authors of the study concluded the low-range devices were electroacoustically inadequate to meet the needs of people with age-related hearing loss based on the spectral shape and levels of gain and output levels.

Question 14

Chan and McPherson (2015)

Answer 14

” Another study used test box measures with laboratory ANSI S3.22-2009 standards and real-ear measurements in a simulated condition to determine if the amplification characteristics of low- cost (less than or equal to $115) OTC hearing aids
o This research indicated that some of the OTC devices were able to match the target gains in simulated conditions, however, the authors note that other factors such as ineffective volume control function, high internal noise levels, and irregular frequency responses may limit the benefit of the devices for people with hearing loss.

Question 15

Aarts and Caffee (2005)

Answer 15

” Examined how well hearing aid software from the manufacturer was able to predict the real ear aided responses (REAR) for a digital behind-the-ear hearing aid in 41 adults.
o These results suggest highlight the importance of on-ear verification of ear canal acoustics using real-ear measures for all hearing aid fittings. The alternative to an audiologist-fit hearing aid will be self-fit devices.

Question 16

Convery et al. (2017)

Answer 16

” evaluated the success rate of a self-fitting process for a commercially available OTC hearing aid in a group of 40 adults with mild-moderately severe hearing loss.
o The authors concluded that although more than half of participants were able to complete the self-fitting task without error, the provision of knowledgeable support by trained personnel, rather than a fellow layperson, would most certainly increase the proportion of users who are able to achieve success.

Question 17

Humes et al. (2017)

Answer 17

” Conducted a double-blind, placebo-controlled, randomized trial with three parallel branches: audiology best practices (AB), consumer decides O-T-C model (CD), and placebo devices (P).
o The AB service-delivery model was found to be efficacious for most of the outcome measures, with moderate or large effect sizes.

Question 18

Kochkin et al. (2010)

Answer 18

” Additionally, professional services provided by audiologists are found to be one of the biggest differentiating factors in terms of hearing aid success, as indicated by the MarkeTrak VIII report

Question 19

Tedeschi and Kihm (2017)

Answer 19

” Investigated the implications of an Over-the-Counter Approach to Hearing Healthcare and observed two significant results
o Approximately ⅙ consumers of OTC hearing aids were not able to self-identify the red flag conditions that would require medical consultation and nearly half were not able to correctly self-assess their degree of hearing loss.
o This study also noted that individuals supported by hearing health care professionals experienced better outcomes in terms of daily device usage, expectations, overall satisfaction, willingness to recommend hearing aids, and perceived success.

Question 20

Chandra & Searchfield (2016)

Answer 20

” Another recent qualitative study evaluated the Internet-based delivery of hearing aids and showed that a large number of study participants reported to have missed the building of trust, value guidance, and expertise of hearing health care professionals

Question 21

Manchaiah et al. (2017)

Answer 21

” Medicare and most third-party payers do not cover this critical aspect of patient care. This is an area where stronger evidence on effectiveness of audiologist-fit devices in addition to counseling and patient support by the audiologist could drive changes in practice and reimbursement, leading to greatly improved patient care at reduced costs to the consumer.

Question 22

The ability to normalize hearing loss and wearing hearing aids ….

Answer 22

o Currently, only about 14% of people with HL use a hearing aid (Chien & Lin, 2012)
o OTC devices may function as a gateway to traditional hearing aids, when hearing degree progresses or optimal performance is not achievable with OTC devices

Question 23

Foster competition in the hearing aid market …

Answer 23

o At the moment, there is a closed hearing aid market driven by about six companies.

Question 24

Broaden consumer choice …

Answer 24

o Ideally, the bill will allow for expansion of access to innovative hearing technology
o Currently, bundled pricing makes it difficult for people with hearing loss to compare costs and shop for best value
o Vigorous competition might spur the development of more appealing, less prosthetic-looking devices-an innovation that has largely eluded the hearing aid industry to date (Blustein & Weinstein, 2016).

Question 25

Drive down prices…

Answer 25

o The delivery and use of OTC hearing aids may also be effective in reducing cost as a barrier to hearing aid ownership.
o In 2015, the President’s Council of Advisors on Science and Technology (PCAST) identified cost as the key barrier to ownership and linked high cost to two interrelated institutional factors:
“ (1) the noncompetitive hearing aid market
“ (2) inefficient hearing aid distribution channels
(Blustein and Weinstein, 2016)

Question 26

The shift to OTC devices would come at the cost of missed opportunities to screen for…

Answer 26

Serious underlying disease.. hearing loss can be caused by underlying medical conditions such as acoustic neuroma (tumor of the hearing nerve), chronic otitis media, or impacted ear wax (Blustein & Weinstein, 2016)

Question 27

Professional guidance is essential to diagnosis, device fitting, and device adaptation, even for those with early hearing loss (the group targeted by PCAST)…

Answer 27

o As changes in hearing loss occur over time hearing aids must be monitored and adjusted through regular visits to an audiologist.
o Hearing aids that are not acoustically appropriate will not provide benefit to the user and if over amplification occurs, further damage to hearing may occur.

Question 28

Additionally, while cost is identified as a key barrier to hearing loss, cost alone should not be the primary reason for the delivery and use of OTC devices…

Answer 28

o Uptake of hearing aids is low, even in nations where aids are available for free.
o In the United Kingdom, for instance, aids are provided by the National Health Service, but uptake and use are not substantially higher there than are uptake and use reported in the United States (Davis et al., 2007).

Question 29

patient satisfaction

Answer 29

” Additionally, patient satisfaction is a key component in the likelihood that a patient will use a hearing aid they have obtained.
“ A hearing aid can only provide cognitive and social benefits when utilized by the patient.
“ It is important to consider not only the appropriateness of the fitting of a hearing aid, but also the patient satisfaction with the device.

Question 30

What additional evidence do you think is needed to address this debate? 


Answer 30

” There is a great need to develop an evidence base with well-controlled and diverse studies relating to the delivery and use OTC hearing devices.
“ This could range from determining the candidacy to studying the user experience, outcome, and economic evaluation.
“ In terms of the devices themselves, what differences will exist between the OTC products and audiologist-fit hearing aids?
“ In addition to differentiating between audiologist-fit hearing aids and the OTC hearing devices, consideration should be given to expected patient outcomes.
o For example, will the consumers of OTC hearing aids have lower expectations given the lower cost of their products?
“ Another avenue for future research and upcoming evidence will be a cost-benefit and cost-effectiveness analysis of the OTC delivery model, once the OTC bill is fully in effect and consumers are more regularly using these devices.
“ Another domain of great importance warranting additional evidence is related to rehabilitation.
o People with hearing loss need and deserve more than hearing aids, alone.
o Aural rehabilitation includes training on use of hearing aids and hearing assistive technologies as well as education on strategies to improve comprehension in challenging listening environments.
“ However, Medicare and most third-party payers do not cover this critical aspect of patient care.
o This is an area where stronger evidence on effectiveness of audiologist-fit devices in addition to counseling and patient support by the audiologist could drive changes in practice and reimbursement, leading to greatly improved patient care at reduced costs to the consumer (Manchaiah et al., 2017).