Hearing Professionals and Consumers Views on OTC Hearing Aids with Vinaya Manchaiah, PhD

opinions on otc hearing aids
July 4, 2023

A new category of over-the-counter (OTC) hearing aids was approved by the U.S. Food and Drug Administration in August 2022.

This week, we bring you the presentation by Dr. Vinaya Manchaiah from this year’s FHH 2023 conference, taking a closer look at the data surrounding both how hearing professionals and consumers view OTC hearing aids and service delivery models.

Full Episode Transcript

Hello everybody.

My name is Vinaya Manchaiah.

I serve as the professor of

otolaryngology head and neck

surgery at the University of

Colorado School of Medicine.

I also have a position as the

Director of Audiology at the

University of Colorado

Hospital UC Health.

My talk today focuses on hearing

healthcare professionals

and consumers views on

OvertheCounter hearing aids.

It before I start the talk,

I wanted to share some

acknowledgment to my colleagues

who are involved in some of the

studies that I’ll be

discussing today.

Also acknowledgments to various

institutions that I’m affiliated

with. In particular,

I wanted to share the website of

our laboratory virtual

Hearing lab.

We are doing a fair amount

of work on hearing aids,

in particular over the

counter hearing aids,

and some of that may be of

interest to you. Also,

thanks to colleagues from

hearing tracker who helped

collect the data that I’ll be

discussing in this presentation,

I do serve as a scientific

advisor for the hearX Group.

So the learning outcomes

for this talk

include these three aspects.

So the first,

at the end of this talk,

hopefully you should be able to

discuss the categories of

hearing devices that are

currently in the US. Market,

describe the views expressed by

hearing healthcare professionals

about OTC hearing aids as well

as consumers about direct to

consumer hearing healthcare

model, and finally,

list a few practice implications

of examining stakeholder views

on OTC hearing AIDS and DTC

hearing healthcare model.

So here is the talk outline.

I’ll start off by providing some

background information,

mainly discussing the device

categories and summarizing

the literature.

Moving on from there,

I’ll discuss a study that was

conducted on hearing healthcare

professionals understanding

their views towards OTC hearing

AIDS and then a study focusing

on consumers and their views

towards direct to consumer

hearing healthcare model and

finally discussing some practice

implications of these studies.


so let’s start by reviewing the

device categories that are

currently in the US. Market.

So in this image,

you see prescription hearing

AIDS to the one end and consumer

audio devices to the other end.

And these are the two device

categories that we are

very familiar with.

And during the last decade,

there has been a merger of these

two device categories,

creating a whole range

of other categories

listed in this image.

So you see that we have device

categories such as Hearables

and PSAPs,

which are direct consumer

devices which are not

meant to be for.

People with hearing glass,

but instead focused on people

with normal hearing as a

hearing enhancement.

Devices to the other side,

next to prescription

hearing AIDS,

you can also see that we have

two types of over the

counter hearing AIDS

since October 2022.

These two categories are in the

US market and the preset OTC

hearing AIDS are the devices

where there are some preset

programs that the users

can choose.

And these are generally at a

lower cost point of something

around $200 to $300,

starting with 200 $300.

And the self fitting hearing

AIDS are the devices where users

have the ability to perform

self testing,

institute testing of

their hearing,

and then using a smartphone


they will be able to program

their hearing aid to their

hearing glass.

And these are generally

of a higher cost.

They range anywhere from six

hundred dollars to two thousand

four hundred dollars,

but generally speaking,

they’re at about eight to $900.

So in my opinion,

the preset OTC hearing AIDS

are very close to PSAPs,

whereas the cell pitting hearing

AIDS are very close to low cost

digital hearing AIDS. So,

to sum this up,

we now have a range of hearing

devices to be able to meet the

needs of a range of consumers.

And let’s also take

a quick look at

the literature in the direct to

consumer hearing device space.

So much of the knowledge on OTC

hearing AIDS actually come from

studies that were done before

2020. At this time,

there was no category

of OTC hearing AIDS.

So much of the research in this

space comes from direct to

consumer heated devices such as

PSAPs or direct mail hearing

AIDS and things like that.

So there have been a few

literature reviews summarizing

the outcomes of direct to

consumer heated devices.

And these studies generally fall

into three categories.

So the first category of studies

focus on acoustic quality

of heating devices.

These are the studies performing

electrocostic testing

in a test box.

And generally some of the early

studies show that the devices,

the direct to consumer devices

such as PSAPs were of very

poor acoustic quality.

Whereas some more recent studies

do highlight that some of the

devices included in the studies

have appropriate acoustic

characteristics for people with

hearing loss, in specific,

people with mild to moderate

hearing loss.

The second group of studies

focus on large scale consumer

surveys. You know,

these are studies involving.

Surveys such as market track,

Eurotrack Japan track and

things like that.

And these studies focus on

outcomes of hearing aid users

in terms of benefit

and satisfaction.

And the studies were mainly

conducted on users of PSAPs and

direct mail hearing AIDS.

And overall,

the large scale consumer surveys

conclude that people who are

using direct to consumer hearing

devices had much lower benefit

and satisfaction when compared

to people who are using

prescription hearing AIDS fitted

by hearing care professionals.

Okay, and finally,

the third group of studies

are clinical trials.

That means these are the studies

that focus on measuring either

self reported outcomes such as

benefit and satisfaction,

or behavioral outcomes such as

speech perception in quiet or

speech perception in noise.

One of the main criticism for

clinical trials and DTC hearing

devices is that most of the

studies are of single group pre

and post design and this means

they did not include

a control group.

And only a few studies have been

well conducted with the control

group as well as using


These studies generally show

that people who used Direct to

consumer hearing devices have

measurable positive outcomes in

terms of self reported benefited

transaction as well as

behavioral measures. Again,

the main criticism on the

literature on this is that most

of the studies were on DTC

hearing devices and there are

only a handful of studies that

were conducted using OTC hearing

AIDS that are currently

in the market.

So this is one of the reason why

the knowledge generated from

this may not be directly

translatable into OTC

hearing devices.


so now let’s look at a recent

study that was focused

understanding on hearing

healthcare professionals views

on over the counter

hearing AIDS.

And this study was conducted in

collaboration with the

Hearing Tracker.

And a Hearing Tracker is a

platform or a website that

provides information about

hearing healthcare and

particularly hearing devices to

consumers as well as to hearing

healthcare professionals.

So the study used a

retrospective cross

sectional design.

So this is a retrospective study

mainly because researchers,

that means we were not involved

in creating the survey.

The survey was designed and

conducted by colleagues at

Hearing Tracker and the survey

was conducted in August 2022

using online platforms such

as Facebook and LinkedIn.

And the survey was done through

a Scout question Scout

platform 653.

Hearing healthcare professionals

completed the survey which

included 22 item questionnaire.

So of the 22 items,

five of the questions were

focused on some basic

demographic information and the

remaining 17 questions were

focused on understanding the

concerns about OTC hearing AIDS.

So one of the key limitations

of this study is that the

demographic information did not

include questions on age,


duration in practice and

things like that

and in terms of the 17 item

concern statements.

So these statements were grouped

into five domains focusing

on safety,

device handling and adjustments,

service delivery,

model counseling and

radiological care and then

finally on optimal benefits

and adverse events.

So these 17 items were worded as

a concern statement and then the

users could answer these

questions using a five point

Like It scale which ranged from

Strongly Agree to Strongly


strongly Agree rated with a five

and Strongly Disagree

rated with a one.

A strongly Agree basically means

that hearing healthcare

professions agree that OTC

hearing AIDS are concerning.

And we did a range of analysis

using this data.

So let’s look at some of

the descriptive data.

So it is interesting

to see that 55%,

that means just over half of the

participants answered saying

that they will support patients

with OTC hearing AIDS

purchased elsewhere.

And nearly quarter 27% of the

participant onset saying that

they will sell OTC hearing AIDS

in their clinic or in their

clinic website.

And also just over 40% also

reported that they will offer

unbundled prices to compete with

OTC hearing aid price.

So these data is fairly similar

to few other surveys that have

been done in this space.

Now let’s move on to looking at

the responses to the 17 concern

statements and again,

you can see that these items

have been grouped into five

domains and safety,

device handling and adjustment,

service delivery,

model counseling and audiology

care and also about optimal

benefit and long term harm.

To simplify these results,

I have clubbed the results into

three items instead of five

items. For instance,

if users said they agree

or strongly agree,

that is included as agree

in blue blue bars.

And then if they answered it as

disagree or strongly disagree,

that has been grouped into

disagree and then the neutral

statements are kept the same.

And as you can see here, we see.

A lot of blue.

That means hearing healthcare

professionals generally agreeing

to concern statements about

OTC hearing AIDS,

sharing the sentiments that they

have a lot of concerns about

OTC hearing AIDS.

When we take a look at these

results closely,

it seems like the concerns are a

lot of concerns tend to be on

safety as well as on counselling

and audiological care.

You see that the items

highlighted here missed medical

red flags not being able to

accurately predict hearing loss

best practice audiologic care is

more important will not be

educated on effective

communication strategies and

also item will not be educated

on realistic expectations.

These are the five statements

where 90% of the users agreed

saying that these are a huge

concern and there are also a few

statements where they had

relatively less concerns.

For instance,

on one of the items on service

delivery model,

that means warranties and return

periods will be worse

as well as on

some of the items on optimal

benefit and long term harm such

as consumers will give up

amplification and do not

provide good value.

Only about 50% of the

participants agree to this

concern statement saying that

those are not a huge concern.

But overall, as you can see,

there is a lot of blue shade in

these bars showing that hearing

healthcare proficients generally

agreed that OTC hearing AIDS

are a huge concern.

When we look at the


we found that there are four

groups of participants and this

included audiologists,

business owners,

hearing instrument specialists

and students.

And when we look at the

association between demographic

characteristics as well

as the responses,

we found some interesting

things. For instance,

audiologists tend to report

at least believe that consumers

having problems in identifying

and addressing common issues

with hearing loss

and OTC hearing AIDS will lead

to greater confusion,

ripped off by bad actors and

warranties and return period

will be worse is more likely

when compared to other users.

On the other hand,

business owners tend to believe

that consumers will give up an

application as well as OTC.

Gates are a significant safety

concern is more likely when

compared to other types

of respondents.

And finally,

we also wanted to look at are

there subgroup of users based

on their responses?

That means are some of the

hearing healthcare professionals

more likely to rate the concern

statement worse compared

to others?

So we performed a cluster

analysis and this resulted

in two clusters.

As you can see,

just over 50% of the users,

51.2% of the users belong

to cluster one,

and we called that as OTC averse.

And then nearly 50%,

49% of the users fell into

a second cluster,

which we named as OTC


And the difference between these

two clusters is that the people

who were in cluster one pretty

much rated every item in the 17

statements either strongly

agree or agree.

That means they had no neutral

or positive sentiments towards

OTC hearing AIDS.

On the other hand, cluster two,

the users in this group,

they rated most of the items

with concerning statements,

but there were some neutral

and positive answers.

That means that this group did

not think that consumers will

give up an amplification if they

tried OTC hearing AIDS.

They disagreed for that

particular statement,

and then they rated either

neutrally or with disagreement

for statements such as OTC

hearing AIDS do not provide good

value and the warranty periods

will be worse,

and things like that.

So overall, again,

it seems like there are two

types of hearing healthcare


Some believe everything about

OTC hearing AIDS is bad,

and others believing mostly that

OTC hearing AIDS are concerning,

although they have some neutral

and positive sentiments.

So now let’s move on from there

to another study that was

published recently

that focused on


So we were not involved

in this study.

This study was conducted by

some of our colleagues at

Northwestern University and

published in JAMA otolaryngology

head and neck surgery.

This is a survey that include

mixed methods.

And the survey was conducted

during March 2022.

And this survey was nested in a

current clinical trial focusing

on OTC hearing AIDS.

So they consecutively recruited

people who participated in

this research study,

who are mainly US residents,

who are at the age

of 50 or above,

with no prior hearing

aid experience.

And more than thousand

participants who completed this

survey were included

in this study.

And the survey for this study

included a 27 item questionnaire

which included some demographic


as well as of questions focusing

on attitude towards direct.

To consumer hearing healthcare

model and they also ran

a bunch of analysis,

descriptive analysis and also

some additional analysis to look

at who are likely to respond in

which way and things like that.

So here is some demographic

information of the consumers who

are included in the study.

As you can see,

the mean age is 61.4 years.

The participants generally

were females,

69% of the participants who

completed the survey were

females and 65% of the

participants were white race and

then 40% of the participants who

were in the study were

also retired.

So this particular slide

provides information about

participants comfort towards

purchasing hearing AIDS online.

And you can see there are

two types of responses.

One response is about

whether users found it

comfortable or uncomfortable to

purchase hearing AIDS online

without a hearing test and then

the same statement about

with hearing test.

That means whether the user

would find it comfortable or

uncomfortable purchasing a

hearing aid online if they were

given a hearing test online.

So the darker the shades

here showing

comfort towards purchasing

hearing aid and the lighter

shades toward the right hand

side basically shows extreme

uncomfortable towards purchasing

hearing AIDS online.

As you can see,

without a hearing test it seems

like a large percentage of

participants find it moderately

are extremely uncomfortable

in purchasing hearing

AIDS online,

whereas if they were given

a hearing test online,

that response shifts

quite a bit.

That means many of the same

respondents are fine purchasing

hearing AIDS online if they’re

given a test, but not all.

So this has some implications

to how we do things

within audiology.

Nowadays there is a boot towards

providing hearing screening


For instance either a tone based

test using various smartphone

applications or using web

widgets to provide things like

digits and noise hearing

screening through practice


So what this data basically

shows that providing some type

of screening or some type of

assessment for consumers will

make a big shift towards whether

or not they purchase as

hearing AIDS online.

And what is also interesting

and surprising.

Seeing from this study is that

most respondents reported

discomfort purchasing hearing

AIDS via direct to consumer

pathways with nearly 84%

indicating that they would

prefer to purchase hearing AIDS

with a hearing healthcare

profession with an

in person model.

And when we look at the response

in relation to demographic


it seemed like older adults and

those who had a higher income

income of 150,000 or more and

also those who are not

interested in purchase hearing

AIDS were less likely to

purchase hearing AIDS online or

pursue hearing health care

online. On the other hand,

those who had previous

experience with direct to

consumer healthcare model are

those who did not have insurance

coverage for the hearing AIDS or

if they were uncertain about

insurance coverage

for hearing AIDS,

then they were more likely to

pursue hearing healthcare


So I found these results to be

interesting because it seems

like there is still a lot of

discomfort from consumers on

pursuing hearing health care

using virtual methodologies.

So now let’s look at some

practice implications that means

what does these results

mean to us?

So one thing that occurred to me

when I was looking at this as

well as looking at over the

counter our direct to consumer

healthcare movement in general.

That means while over the

counter hearing AIDS

are relatively new,

we have over the counter

healthcare products.

For instance,

OTC medications are various

types of direct to consumer

healthcare products that have

been available in the market

for several decades.

And when such products became

available, for instance,

when OTC medications became

available in the US market

several decades ago,

there were fairly similar

concerns from physicians as well

as consumers about using

OTC medications,

including concerns about cost

and adverse events and

things like that.

Whereas now if you move forward

a couple of decades after we see

that OTC medications have

integral part of healthcare


So that means when we see

our primary care,

if they need to prescribe

certain drugs which are

over the counter,

they would basically discuss

that with us. And in fact,

many of us would now seek over

the counter medications on a

routine basis without any fear

towards such medications.

So what this basically tells me

is that awareness and education

towards OTC hearing AIDS may

address some of the concerns

expressed both by hearing

healthcare professionals

as well as consumers.

So I talked to audiologists

across the US quite often and

most audiologists have not

had any experience with.

OTC hearing AIDS.

They have not had any hands on

experience. And in my opinion,

that may be one of the concerns

why the survey results were

fairly negative towards

OTC hearing AIDS.

And the second point I want to

make is by using some of the

recently published data

from Larry Humes on

unmet needs in in healthcare.

So this is the busy slides,

and let me just kind

of go through this.

So the top bars here with blue

shades basically show

data for males.

And the bottom graphs with pink

shades show the data

for females.

And the left hand side bars

basically show data based on

hearing sensitivity that is

measured using pure tone

audiogram and the hearing that’s

classified using word

as organization,

hearing impairment,

grade into mild,

moderate and moderately severe.

And in the right hand,

we have data based on trouble

hearing, in other words,

self reported hearing disability

and again classified into

a little trouble,

moderate trouble and

a lot of trouble.

And what you can see here

is that those who are currently

using hearing AIDS or ever used

a hearing aid are assistive

listening devices tend to be

very small in the mild category

or a category with

a little problem.

That means nearly 90% or more of

the people with mild hearing

impairment category doesn’t own

a hearing aid or have not

used a hearing aid ever.

And that kind of percentage

tends to come down when we go

moderate and moderately

severe category.

That means to

say that there seems to be a

large unmet need of hearing

health care,

particularly in the

mild to moderate

hearing glass group.

And when you look at the OTC

hearing AIDS and these are meant

to be for people with perceived

mild to moderate hearing loss,


So one way of thinking about the

OTC space is that the OTC

hearing AIDS are meant for

people from a different

population than those who

we serve in the clinic.

And the final point I want to

make about practice implication

is the difference between

need and demand.

So the previous slide,

an unmet need basically

suggested that there are a lot

of people who could be served

using a range of devices

including OTC hearing AIDS.

But in my opinion,

I don’t think there has been a

clear demand that has been

demonstrated yet.

At the University of Colorado

Health, UC Health,

where I currently practice and

oversee clinical operations,

we have just.

Just introduce the OTC hearing

aid protocol that includes

kind of two steps. First,

after we complete

a hearing test,

we let the patient know if

they’re a candidate for OTC

hearing aid or if they’re not a

candidate for various reasons.

And in the second step,

if they do come back for a

hearing aid consultation


we do make sure to discuss OTC

hearing AIDS as one of the

options if they are

a candidate aid.

If there are people with mild

to moderate hearing us,

then we bring up the discussion

of OTC hearing AIDS into the

consultation session.

And what we are seeing is that

even after mentioning about

OTC hearing AIDS,

very few patients kind of ask a

follow up questions that show

interest in OTC hearing AIDS.

In other words,

they are interested in they’ve

come to us because they’re

interested in pursuing

prescription hearing AIDS.

So what this is telling

us is that

this may be a separate


And one thing that has also

became apparent to us doing

this is basically

discussion about OTC hearing

AIDS may help us build trust

in hearing healthcare


I had a patient last week who

was a 67 year old female with

multiple health problems and

with a mild to moderate

sloping hearing glass.

I did recommend her to come back

to us for a hearing

aid consultation,

and her immediate response was

that she has multiple health

issues and her insurance does

not cover hearing AIDS and there

is no way she will come back.

And then I also discussed the

option of OTC hearing AIDS and

talked to her saying that some

of the preset OTC hearing AIDS

could be as low as 200 $300.

And she was presently surprised

and wanted to kind of look into

that more with the view that she

wanted to get some help using

these OTC hearing AIDS as

hearing AIDS are unaffordable.


affordability may not be an

issue for many patients,

but I just wanted to kind of

make a point saying that there

are people who could use OTC

hearing AIDS for various


And just to summarize what we’ve

been talking so far,

based on the recent studies,

it is kind of apparent that both

hearing healthcare professionals

as well as consumers have

hesitation towards OTC hearing

AIDS and direct to consumer

hearing healthcare models.

It may take time,

potentially a decade or longer,

for OTC hearing AIDS and direct

to consumer hearing healthcare

models to take off,

in my opinion.

Looking at the hearing aid

landscape as well as some recent

data that is coming out,

it is likely that the OTC

hearing aid consumers are a very

different group compared to

clinical samples that we

are currently serving.

Efforts are.

Needed to educate hearing

healthcare professionals as well

as our consumers on

OTC hearing AIDS,

as well as efforts are needed to

remove barriers to facilitate

uptake of OTC hearing AIDS and

direct to consumer hearing

healthcare models.

So with that note,

I conclude my talk.

Here are my contact details.

I’ll be happy to take any

questions if you have by email.

Also what wanted to share

details of an event?

I conduct an annual seminar

in Colorado.

This is a hybrid event

opportunity for people to

participate either in

person or online.

And this will be happening on

July 29. And this year,

the seminar theme is an

OTC Hearing AIDS.

So if you’re interested

in this topic,

you’re welcome to join us.

So here is the the event link

as well as a QR code.

So thank you all for joining

this and I hope to hear from you

if you have any questions.


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About the Panel

Dr. Vinaya Manchaiah, AuD, MBA, PhD serves as the Professor of Otolaryngology-Head & Neck Surgery at the University of Colorado School of Medicine and as the Director of Audiology at the University of Colorado Hospital (UCHealth). He is the Principal Investigator at the Virtual Hearing Lab (www.virtualhearinglab.org). He also has a position as an Extraordinary Professor at the University of Pretoria, South Africa, and an Adjunct Professor at the Manipal Academy of Higher Education, India. He has authored over 200 scientific manuscripts and 5 textbooks. Full bio is available on: www.vinayamanchaiah.com.


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