Close to 30 million adults living in the U.S. have some degree of hearing loss. Despite the high number of people affected by hearing loss, only about one-fifth of those who could benefit from a hearing aid seek intervention. Using hearing aids may reduce the frequency or severity of cognitive decline, depression, and other health problems in adults. Added benefits can include improved social participation and a better quality of life. To increase the public’s access to hearing aids and improve hearing, the FDA established a new category of over-the-counter (OTC) hearing aids for adults 18 years of age and older with perceived mild to moderate hearing loss that went into effect on October 17, 2022.

Interpretation of the FDA OTC hearing aid bill-what is the future of OTC hearing aids?

Recently, the “2019 New Audiovisual Hearing Industry Summit”, sponsored by the Beijing Science and Technology Association and co-organized by the Hearing Services Industry Committee, successfully concluded in Suzhou. A total of more than 200 hearing aid fitters, store operators, managers of domestic and foreign manufacturers and distributors from all over the country attended the conference. The conference lasted 3 days. The conference included a small member meeting, a dinner, an important press conference, 4 theme forums, a case study, 2 round table forums, and 2 corporate visits. A total of 20 topics The speakers and 10 guests of the round table forum made a wonderful sharing.

In the morning of November 16th, in the theme forum of “Service Concept” at the 2019 New Audience Hearing Industry Summit, Adnan Shennib shared a keynote speech entitled “How does the future of OTC hearing aids go?”
Specifically include: U.S. OTC / DTC hearing aid trends and policies, the biggest obstacles affecting hearing aid sales, the interpretation of the 2017 OTC Act, the current state of the U.S. OTC / DTC market, how audiologists / fitters respond to the OTC market, next-generation OTC hearing aids, etc. .

First Mr. Adnan explained the concepts of OTC and DTC. DTC: Direct-To-Consumer. It belongs to the category of hearing aids, and users need to sign a medical waiver (Medical waver) before they can buy directly on the Internet, pharmacies and other channels. OTC: Over-The-Counter. Hearing aids in this category can be purchased directly from the Internet, pharmacies and other channels without a medical exemption.
US Hearing Aid Policy
Hearing aids are medical devices regulated by the FDA. Most hearing aids are sold by audiologists / audiologists. Users who want to purchase hearing aids from audiologists / auditors online, pharmacies, etc. need to sign a medical waiver. Because of this veiled sales model, the development of direct-sale channels has been unimpressive.
He Chuanpu signed the OTC hearing aid related bill in 2017, but the FDA has not announced the OTC hearing aid category, so the merchants have not yet been able to sell under the name of “OTC hearing aids”.

The biggest obstacle to hearing aid sales

The average retail price of hearing aids in the United States is $ 2400, and the lowest penetration rate of hearing aids is only 14-20%. These factors have led users to choose to purchase PSAPs personally assisted listening products. (Personal Sound amplfication China refers to PSAPs as sound amplifiers)

Interpretation of the 2017 OTC Act

What does the OTC Act 2017 mean?

Medical-grade hearing aids will be sold directly to end users. The FDA will develop a new product classification and set product standards for OTC hearing aids.

Why can the OTC bill be signed?

OTC hearing aids can reduce the cost for consumers to obtain hearing aids; increase consumers’ channels to purchase hearing aids; stimulate the birth of new products and services.

When does the bill come into effect?

The Act was signed in August 2017, and the FDA will complete all relevant work for the effectiveness of OTC hearing aids within 2020. The hearing aid industry responded very negatively, but they couldn’t provide a better solution, so the bill passed smoothly.

U.S. OTC / DTC market status

“OTC hearing aids” have not yet been opened in the US market, but retailers are eager to move in the future. On the one hand, online retailers are working to upgrade and provide more comprehensive PSAPs. Some products can already support popular emerging technologies such as remote fitting. On the other hand, CVS, COSTCO – like American pharmacy predators have introduced the sales of PSAPs. OTC hearing aids will be introduced in the future.
Cable/Online retailers report an annual growth of 46%. The potential of this emerging market is still huge, and it is estimated that the current annual growth is 20-30%.

Big players in OTC / DTC market

CVS and Beurer, NANO hearing aids can provide top new technologies and products for the OTC / DTC market. Big players in the consumer electronics industry, such as BOSE, also announced their entry into the OTC / DTC market.

The impact of OTC / DTC market

The OTC market will have a huge impact on the industry and consumers, and some changes will drive the full potential of OTC / DTC. The most obvious impact is that consumers can get lower price hearing aids, and more high-quality hearing aid products will flood into emerging channels and markets.

U.S. President Trump has signed the Food and Drug Administration Reauthorization Act of 2017, which includes an OTC OTC Hearing Aid Act that will include hearing aids in OTC OTC products. After the law goes into effect, adults with mild to moderate hearing loss can purchase OTC hearing aids directly.
Prior to this, any hearing impaired patient in the United States must be selected and equipped with hearing aids by professional hearing care professionals.
This also means that hearing aids have changed from high-cold male / female goddesses insulated from the general public to cordial and friendly friends next door. More and more ordinary people will have the opportunity to access hearing aids and learn how it can help hearing impaired friends overcome inconvenience in life and improve the quality of life!

Industry response to OTC hearing aids

Favorable. Because OTC hearing aids have a wider sales channel, this means that more potential consumers will recognize hearing loss, and indirectly, it will also drive the perception of hearing / hearing aid fitters. And hearing professionals / hearing aid fitting professionals with professional backgrounds will have the main voice in the development of new products in the OTC channel.

How to deal with the OTC market?

The explosion of the OTC market means that audiologists / fitters can use their professional knowledge and rich experience to participate in the development and production of OTC products, at the same time participate in pre-market clinical trial research, or provide professional OTC products. Hearing Services Consulting.


Facing the OTC market, hearing aid brands are not yet ready. The existing products are not completely suitable for the OTC market. Although various innovations have emerged in the hearing aid industry in the past 5 years, these technological innovations have not been able to promote the explosive growth of the hearing aid industry. Consumers demand new products and innovations.
It has nothing to do with price, channels and technology, but it comes from the stereotypes of the public about hearing aids. Hearing aid users are defined as aging and hearing impaired, which greatly limits the external development of hearing aids. Therefore, brand owners should start with user needs and introduce new designs, different functional designs, or provide additional functions beyond “listening.”
Mr. Adnan, using wearable products as an example, explained that making users long for ownership is more important than having to own it. How to make hearing aids get rid of stereotypes and become more “high-tech” and “healthier” is worth considering by hearing aid brands.

Feasibility of next-generation OTC hearing aid development

The existing core technology of hearing aids cannot yet support the development needs of new OTC hearing aids; the existing technology solves the “necessity of hearing” and ignores the “hearing of hearing”; adding other functions (such as health monitoring) ) Can effectively change consumers’ stereotypes about hearing aids.

The best OTC hearing aid supplier in China

Huizhou Jinghao Medical Technology CO., LTD. is the sole listed hearing aids/ hearing amplifier manufacturer in China, be famous for provide good quality and good price hearing aids/hearing amplifier.
Jinghao Medical passed BSCI, ISO13485, ISO9001, C-TPAT, SQP ,CVS HEALTH  etc audit ,and all products with CE, RoHS, FDA certificates. With more than 30 experienced engineers R&D department, Jinghao have the ability to do ODM & OEM project.
Typical OTC Hearing aids Customers include CVS HEALTH, BEURER, AEON (JAPAN) , etc.

To sum up

The potential of the OTC / DTC market is huge. The hearing aid manufacturing industry has yet to find a product that really responds. Resolving consumer stereotypes is a prerequisite for high market growth. Only breakthroughs in core technology can create innovative products and unlock the OTC market.

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JH-A610 mini rechargeable ITE hearing aids prevent feedback

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1. In ear detection without squeal prevent feedback
Reduce risk of hearing damage from squeal, power on with detection of placing in the ear canal, turn off once removed.

2.Comfortable Fit
Perfected Ergonomics
About 3g Light weight Naturally lay in your ear canals for a tight, secure fit during extended use.

3.Big button , Modify At Ease
Up to 190° turn on adjustment knob,easy operation

4. NTC Protection
Automatically turn off when temperature reaches 40℃ for safety

5. Easy to Charge
2 hours full charge gives you 12 hours of listening on one charge.
Re-charge quickly for up to 3 times and keeps you listening up to 36 hours.
(Note: Tests conducted in JINGHAO lab, results may vary according to usage.)

JH-DW2 Over the Counter Rechargeable Hearing Aids with Bluetooth and Microphone

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Hearing aids with Bluetooth and microphone technology allow you to connect to your smartphones wirelessly. This connectivity lets you stream audio directly to your hearing aids, eliminating the need for headphones or additional accessories. With over-the-counter rechargeable hearing aids with bluetooth and microphone functionality, you have hands-free phone conversations and hear clearly in crowded environments. Bluetooth hearing aids with microphone support you to control various settings and features through the hearing control app. This app allows you to adjust volume levels, change programs, and customize settings based on your preferences and specific listening environments.

  • Multiple directionality microphones and digital signal processing
    (channels)
  • 4 Hearing programs
  •  Binaural type
  • Hearing App (iOS and Android)
  • Direct Audio Streaming from iOS devices or Android devices
  • Wireless programming
  • Feedback cancellation & WDRC
  • Multi-function Button
  • 3-in-1 Recharging Base
   

JH-W3 TWS BTE Rechargeable Bluetooth Hearing Aids with OTC Hearing Amplifier Smart App

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JH-W3 TWS BTE rechargeable bluetooth hearing aids combine the benefits of rechargeable batteries with the convenience of bluetooth connectivity. These hearing aids can be easily charged using a 3-in-1 portable charging case. These rechargeable bluetooth hearing aids can wirelessly connect to compatible devices such as smartphones, tablets, and computers. This connectivity enables users to stream phone calls, music, podcasts, and other audio directly to their bluetooth rechargeable hearing aids without needing additional accessories.

  • Smartphone App (iOS/Android)
  • Personal each ear independently via the App
  • Control EQ settings for optimal audio experience
  • 3-in 1 Multifunction Charging Case
  • TV Connect
  • Digital Sound Processing
  • Bluetooth 5.0
  • IPX6

   

$899.99

JH-A32B Wireless TWS Design Digital Rechargeable Hearing Aids in ear detection

  • Do Sports with Wonderful Sound Experience
  • High-performance dual microphones per ear – Catch more of the ambient sounds of your surroundings, whether it’s in-flight noise, city traffic or office chatter.
  • 4 Different Hearing programs – 4 channels Digital signal processing with noise reduction/WDRC/AFC
  • “Quick charge Save time and effort – 15 minutes Quick charge for three-hour hearing back”
  • IPX4 Water-resistant for everyday use – With an IPX4 water resistance rating, splashes and sweat won’t stop these hearing aids – so you can keep on moving to the sport.
  • In-ear Detection – The in-ear detection sensor will carry out real-time intelligent detection on the operation status of the hearing aid.The sensors to identify when you’re wearing the hearing aid
  • Fashion TWS Design – Fashion TWS Design and embarrass Free
  • Comfortable Fit In The Ear – Ergonomic fit directly in the ear, comfortable to wear the whole day
  • Firm & Comfortable, Tailored to Exercise – The unique design enhances the firm, stable fit of the earphones and prevents them from dropping during intense exercise.

JH-A39H Rechargeable ITE Digital Hearing Aid

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  • 16-Channel DSP
  • Adaptive Feedback Canceler
  • Comfortable and secure fit
  • Easy Operation
  • 2Hrs Charging Time Up to 20 hours Auxiliary Hearing (On a single charge)
  • Up to 60 hours with charging case

JH-A17BT Non-prescription OTC CIC Hearing Aids

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Non-prescription hearing aids are designed to address mild to moderate hearing loss, and to provide an accessible and affordable option for individuals seeking amplification. JH-A17BT OTC hearing aids are designed to be extremely discreet and difficult to detect when worn. These hearing aids without prescription are engineered to blend seamlessly with the wearer’s natural appearance, making them virtually invisible to others.

  • Built-in high-capacity high-quality battery
  • Quick-charge: 15 minutes quick charge for 5 hours hearing back
  • Fashionable In the ear design
  • Comfortable and different shape earplugs can fit all people
  • USB charging box, small and can charge anywhere, anytime
  • USB charging box can support 3 times charging for pair

JH-A61A Rechargeable Smart OTC Hearing Aids

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JH-A61A smart hearing aids are a kind of otc in-ear hearing aid, which refers to advanced otc in-ear hearing aid device that incorporates digital technology and connectivity features, to enhance the overall hearing experience. The smart hearing aids have a smart tape to adjust the sound wave, providing a superior hearing performance.

  • In ear detection turn on/off without squeal
  • Comfortable fit, perfected ergonomics, light weight with only 2.7g/per
  • NTC protection, automatically turn off when temperature reaches 45°C for safety
  • Quick 15-minute charge provides 3+hours hearing back
  • Portable charing case can recharge each device at least 3 times

JH-D59 Rechargeable Digital BTE Hearing Aid

(4 customer reviews)
  • Sound Clearly
  • Digital Sound Processing
  • Rechargeable Hearing Aids

JH-A32C Smart & Self-fitting Rechargeable Digital OTC Bluetooth Hearing Aids

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Smart and self-fitting rechargeable digital OTC hearing aids with Bluetooth are advanced devices that combine the benefits of rechargeable batteries, digital sound processing, and wireless connectivity.

  • Otc bluetooth hearing aids, 5.0 Bluetooth function, faster and more stable connection
  • Fully customizable for personalized hearing
    -Smartphone APP(iOS/Android)
    -Smart control to adjust the volume/EQ/MPO/modes etc
  • TV Connect
  • Digital Sound Processing ,12 EQ Bands
  • IP64 Water and Dust Resistance
  • Firm & Comfortable Tailored to Sport
   

JH-A39 Rechargeable in the Ear Hearing Aids

(8 customer reviews)
Select Color:
 Black  White

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JINGHAO Rechargeable in-the-ear (ITE) hearing aids are compact devices that fit inside the ear and are designed to provide an improved hearing for individuals with hearing loss. Unlike traditional hearing aids that use disposable batteries, rechargeable in the ear hearing aids come with built-in rechargeable batteries.

JH-A39 Rechargeable in the Ear Hearing Aids

  • JH-A39 rechargeable in the ear hearing aidshave excellent design, quick and simple charging, and easy-to-use, completely wireless earbuds that also double as sound amplifiers.
  • JH-A39rechargeable ITE hearing aid can amplify voices for easy conversation
  • Discreet, behind-the-ear design with three sizes of ear tips
  • Rechargeable batteries for up to 16 listening hours
  • Amplifies voices for mild hearing loss
  • JHa39 hearing aid can reduce ambient noise for easy conversations
  • Discreet, inner ear design with comfortableear tips
$99.00

JH-D26 Rechargeable BTE Hearing Aid

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  • Comfortable BTE model, easy to use
  • Tiny size, invisible behind the ear
  • Wire thin receiver tube invisible to the eye
  • Fits ear canal nicely without discomfort
  • Easy to use Up and Down volume buttons
  • Low Battery Warning
  • Frequency controls for unique environments
  • Normal/everyday frequencies
  • Noise Reduction frequencies
  • Television frequencies
  • Feedback Control
  • Automatic Noise Reduction capabilities
  • Automatic Feedback Cancelled