What are Ear Molds for hearing aids?

What are Ear Molds for hearing aids?

When a hearing loss patient selects a hearing aid style—such as BTE (Behind The Ear) hearing aids, RIC, CIC, or OPEN FITcustom-fit earmolds (Ear Molds) are often needed to ensure the best performance, staying in the ear, keeping out noise and giving comfort, especially in noisy situations.

An open tube/tip doesn’t keep the noise out, but an ear mold can. An ear mold is a piece of plastic, acrylic, silicone rubber or other material shaped to fit a patient’s ear canal, and/or the outer ear structure (concha) surrounding the ear canal.

Ear mold styles vary according to level of hearing loss, and the style of hearing aid with which they’re paired. In many cases, ear molds sit inside the ear canal, hidden from view. Other times, lab ear molds sit in the concha bowl as well as in the ear canal.If you require a custom ear mold, your hearing care professional will take an impression of your ear canal and outer ear using a quick-setting plastic or silicone-like substance. The ear impression is sent to a specialty lab where it’s turned into a replica of your ear shape.

A good Custom Ear mold can greatly enhance your listening experience. Custom Ear molds are used with Behind-The-Ear hearing aids and Body worn hearing Aids. They are the solution for many common hearing aid problems.

THERE ARE 2 WAYS TO MAKE A CUSTOM EAR  MOLD FOR YOUR HEARING AID.

First, DIY (Do It Yourself)   https://earmolds.info/earmold-kits  

2nd, have your hearing aid provider make an impression of your ear and send it to a remote ear mold lab. In order to have a custom earmold made by your Dealer/ provider, Specialist or Audiologist, they need to have impressions of  your ear. Making impressions of your ears takes about 15 – 20 minutes.

A Custom Earmold will:

1) reduce the possibility of feedback since a form-fitting Custom Earmold provides a better airtight seal in the ear vs. a generic ear piece dome/tip, (the ‘mushroom’ insert),

2) keep the hearing aid more secure in the ear since it will take advantage of all the curves and contours of the user’s ear to lock it all in place,

and 3) help reduce the occlusion effect. Occlusion is where a person’s ears feel ‘stuffy.’ People describe occlusion as if they are talking in a barrel, an echo effect, or similar to having water in their ears. It’s the same effect you have when you talk if your ears are all plugged up.The occlusion effect is reduced by having the custom earmold vented (or loose fitting). A ‘breathing hole’ or ‘channel’ is usually drilled through the canal portion. This allows the chamber that’s created between the end tip of the earmold and a person’s eardrum to ‘breathe’.  Sometimes too much of the volume of the hearing aid escapes through the vent hole causing the aid to feedback/whistle/ squeal. So you can include a series of small vent plugs (they look like tiny little bushings and have different sized inner diameter holes in them) or simply remove a channel along one side or along the bottom, but at the same time restricts the outward flow of air volume to a reduced point so the aid does not feedback. Sometimes the answer is to plug the hole with lambs wool, to act as a filter.

Apple offers new AirPods Pro low cost hearing aids, $249.

Apple reveals new AirPods Pro, available October 30

All-New Design Features Active Noise Cancellation for Immersive Sound

The new AirPods Pro.
AirPods Pro bring Active Noise Cancellation with superior sound to the AirPods family.

Cupertino, California — Apple today announced AirPods Pro, an exciting addition to the AirPods family that features Active Noise Cancellation and superior, immersive sound in an all-new lightweight, in-ear design. AirPods Pro are available to order on apple.com and the Apple Store app starting today and in stores beginning Wednesday, October 30.“AirPods are the best-selling headphones in the world. The one-tap setup experience, incredible sound and iconic design have made them a beloved Apple product, and with AirPods Pro, we’re taking the magic even further,” said Phil Schiller, Apple’s senior vice president of Worldwide Marketing. “The new in-ear AirPods Pro sound amazing with Adaptive EQ, fit comfortably with flexible ear tips and have innovative Active Noise Cancellation and Transparency mode. We think customers are going to love this new addition to the AirPods family.”

An AirPods Pro user waiting for a train.
The comfort and fit of AirPods Pro feel natural whether listening to music with Active Noise Cancellation turned on or having a face-to-face conversation while in Transparency mode.

AirPods Pro join the existing AirPods line in delivering an unparalleled wireless audio experience. Each model uses advanced technology to reinvent how people listen to music, make phone calls, enjoy TV shows and movies, play games and interact with Siri. The magical setup experience customers love with today’s AirPods extends to AirPods Pro. By opening the charging case near an iOS or iPadOS device and giving it a simple tap, AirPods Pro are immediately paired to all the devices signed into a user’s iCloud account, including iPhone, iPad, Mac, Apple Watch, Apple TV and iPod touch.

All-New Design

AirPods revolutionized the wireless audio experience with a breakthrough design, and now AirPods Pro take it even further with a new class of lightweight, in-ear headphones engineered for comfort and fit. Each earbud comes with three different sizes of soft, flexible silicone ear tips that conform to the contours of each individual ear, providing both a comfortable fit and a superior seal — a critical factor in delivering immersive sound. To further maximize comfort, AirPods Pro use an innovative vent system to equalize pressure, minimizing the discomfort common in other in-ear designs. AirPods Pro are sweat- and water-resistant, making them perfect for active lifestyles.1

AirPods Pro with charging case.
AirPods Pro bring the magic of AirPods to an all-new lightweight, in-ear design.

Active Noise Cancellation

Active Noise Cancellation on AirPods Pro uses two microphones combined with advanced software to continuously adapt to each individual ear and headphone fit. This removes background noise to provide a uniquely customized, superior noise-canceling experience that allows a user to focus on what they’re listening to — whether it’s a favorite song or a phone conversation.The first microphone is outward-facing and detects external sound to analyze environmental noise. AirPods Pro then create an equivalent anti-noise that cancels out background noise before it reaches the listener’s ear. A second inward-facing microphone listens toward the ear, and AirPods Pro cancel remaining noise detected by the microphone. Noise cancellation continuously adapts the sound signal 200 times per second.

Immersive Sound

AirPods Pro deliver superior sound quality with Adaptive EQ, which automatically tunes the low- and mid-frequencies of the music to the shape of an individual’s ear — resulting in a rich, immersive listening experience. A custom high dynamic range amplifier produces pure, incredibly clear sound while also extending battery life, and powers a custom high-excursion, low-distortion speaker driver designed to optimize audio quality and remove background noise. The driver provides consistent, rich bass down to 20Hz and detailed mid- and high-frequency audio.

A deconstructed view of the components of AirPods Pro.
AirPods Pro are packed with audio innovation to deliver superior sound and an immersive noise-canceling experience.

Transparency Mode

Transparency mode provides users with the option to simultaneously listen to music while still hearing the environment around them, whether that’s to hear traffic while out for a run or an important train announcement during the morning commute. Using the pressure-equalizing vent system and advanced software that leaves just the right amount of noise cancellation active, Transparency mode ensures that a user’s own voice sounds natural while audio continues to play perfectly.Switching between Active Noise Cancellation and Transparency modes is simple and can be done directly on AirPods Pro using a new, innovative force sensor on the stem. The force sensor also makes it easy to play, pause or skip tracks, and answer or hang up phone calls. Users can also press on the volume slider in Control Center on iPhone and iPad to control settings, or on Apple Watch by tapping on the AirPlay icon while music is playing.

AirPods Pro with iPhone 11 Pro.
A quick tap on the volume slider in Control Center makes it easy to switch between Active Noise Cancellation and Transparency modes.

Performance and Battery Life 

The size and performance of AirPods Pro are made possible by a revolutionary system-in-package (SiP) design with the Apple-designed H1 chip at its core. The H1 features 10 audio cores and powers everything from sound to Siri. The extremely low audio processing latency of H1 enables real-time noise cancellation, delivers high-quality sound using adaptive technology and responds to hands-free “Hey Siri” requests — all at once.AirPods Pro feature the same great battery life as AirPods with up to five hours of listening time. In Active Noise Cancellation mode, AirPods Pro deliver up to four and a half hours of listening time and up to three and a half hours of talk time on a single charge. Through additional charges from the Wireless Charging Case, AirPods Pro deliver over 24 hours of listening time or over 18 hours of talk time.2 Charging is as simple as placing the AirPods case on a Qi-certified charging mat or using the Lightning port while on the go.

The H1 chip in AirPods Pro.
The size and performance of AirPods Pro are made possible by Apple’s innovative system-in-package (SiP) design, featuring the H1 chip that powers everything from sound to Siri.

Additional Features

  • The Ear Tip Fit Test helps ensure users get the best audio experience from AirPods Pro by testing the quality of the seal and identifying the best ear tip size for them. After placing AirPods Pro in each ear, advanced algorithms work together with the microphones in each AirPod to measure the sound level in the ear and compare it to what is coming from the speaker driver. In just seconds, the algorithm detects whether the ear tip is the right size and has a good fit, or should be adjusted to create a better seal.
  • Voice-activated Siri uses the H1 chip to enable hands-free “Hey Siri” to play a song, increase the volume, make a call or get directions. 
  • Audio Sharing makes it easy to listen to the same song or watch the same movie with a friend by simply bringing a second pair of AirPods close to iPhone or iPad.3
  • Announce Messages automatically and conveniently speaks incoming messages as soon as they arrive, and when on a phone call or sharing media via Audio Sharing, Siri knows not to interrupt.4

Pricing and Availability

  • AirPods Pro will be available for $249 (US) and are available to order from apple.com and in the Apple Store app in the US and more than 25 other countries and regions. AirPods Pro will start shipping on Wednesday, October 30 and be available in stores beginning later this week (varies by country and region).
  • AirPods Pro require Apple devices running iOS 13.2 or later, iPadOS 13.2 or later, watchOS 6.1 or later, tvOS 13.2 or later, or macOS Catalina 10.15.1 or later.
  • AirPods with Charging Case are available for $159 (US) and AirPods with Wireless Charging Case are available for $199 (US). Customers can order the standalone Wireless Charging Case for $79 (US).
  • Customers can add personal engraving to AirPods Pro, AirPods with Charging Case and AirPods with Wireless Charging Case for free on apple.com and the Apple Store app.

Chocolate can reduce hearing loss, study reported

A team of researchers in Korea conducted a rigorous nationwide study of the chocolate consumption of 3,575 subjects—between 40 and 64 years old—and the results were startling: Hearing loss was significantly lower for those who regularly consumed chocolate:

The rate of any hearing loss (unilateral or bilateral) in the subjects who consumed chocolate (26.78% (338/1262)) was significantly lower than that in those who did not (35.97% (832/2313)) (p < 0.001). Chocolate consumption was independently associated with low odds of any hearing loss (adjusted odds ratio = 0.83, 95% confidence interval = 0.70 to 0.98, p = 0.03).

Korean National Health and Nutrition Examination Survey

The researchers concluded that “the severity of hearing loss was inversely correlated with the frequency of chocolate consumption.” In other words, the more often you eat chocolate, the better your odds of avoiding severe hearing loss.

A national nutritional/medical survey

The study used data from the Korean National Health and Nutrition Examination Survey (KNHANES), which records the health and nutritional status of Koreans. Respondents were given hearing threshold tests to determine the presence and degree of sensorineural hearing loss.

To control for other pathologies that may have contributed to hearing loss, the researchers performed rigorous physical examinations on each subject. Subjects also provided detailed information on their consumption of chocolate and other foods. Information on the frequency and quantity of food consumption summarizing the subjects’ previous year of eating was collected by trained dietitians.

The research did not identify exactly how or why chocolate prevents hearing loss. However, researchers said the size of the sample and rigor of their analysis gave them the confidence to come to a strong conclusion: “Our results suggest that chocolate plays an oto-protective role against hearing loss.”

Cocoa may be key to preventing hearing loss

Cocoa is known to be an anti-oxidant that can help prevent cardiovascular inflammation. The researchers hypothesized that the same effects could reduce vascular hypertension in the ear, a condition that is associated with hearing loss. While this causative link was not definitive, the researchers did note a high correlation between chocolate consumption and reduced vascular hypertension:

Those who did not consume chocolate had higher risks of hypertension and dyslipidemia than did those who consumed chocolate. Chocolate exerts antioxidant and anti-inflammatory effects and has been shown to have therapeutic benefits for patients with cardiovascular diseases. Specifically, cocoa, a major ingredient of chocolate, attenuates vascular risks by reducing blood pressure and improving endothelium-dependent vasodilation. In line with this, several investigations demonstrated the causal relationship between vascular risk factors and hearing loss. Thus, our results suggest that chocolate decreases the rates of hypertension and dyslipidemia, which enables the preservation of hearing.

Korean National Health and Nutrition Examination Survey

Unfortunately, other beloved foods don’t appear to have the same preventative properties. Specifically, the researchers l looked into the consumption of ice cream, cake, and cookies. The data indicated that these foods had no impact, positively or negatively, on rates of hearing loss: “there was no association between hearing loss and the consumption of sweet products without cocoa.”

Chocolate doesn’t help relieve tinnitus

The researchers also investigated the relationship between chocolate consumption and tinnitus, the annoying ringing, buzzing, humming and other sounds that many people have in their ears.

Because many people who have hearing loss also have tinnitus, the team hypothesized that chocolate consumption might also help prevent tinnitus, but it didn’t.

Earmold Dome slipping in ear?

If your Dome (eartip) slips in or out of your ear, you are not alone. It is a common problem and it is no wonder. The Domes are round but your ear csnal is irregular and more oval shaped.

The solution is easily and inexpensively solved. Instead of using a tight-fit dome, use a slightly smaller size (preferably OPEN FIT), for comfort. Then mix a small portion of HCPB Medical Grade silicone putty and add it to the dome and tube before inserting it in the ear

The new cstom fit earmold that you made in just 3 minutes will now comfortably lock it in the ear and a side effect will be improved hearing. There will no longer be any dome slippage in the ear and it will prevent the hearing aid from falling off the ear. This will also prevent the dome tip from coming off the tube and staying in the ear, if you have used an Open (not closed ) dome.

For RIC Hearing aids https://earmolds.info/ric-4-ear-molds-kit/ $19.88 Makes 4 earmolds kit For 24 bulk earmold kit https://earmolds.info/ric-hearing-aid-ear-molds/ $29.77

For OPEN FIT Hearing aids: 4 earmold kit https://earmolds.info/open-fit-4-ear-molds-kit/ $19.88 For 24 bulk earmold kit: https://earmolds.info/open-fit-24-earmold-kit-2/ $29.77

More information https://earmolds.info/

HEARING in NOISE and difficult situations

“Live Transcribe” now helps you communicate in the difficult listening situations.

With “Live Transcribe”, you can see words appear on your Android phone as they’re spoken.

If it seems like someone says New York, but they’re actually talking about new Yorkshire terriers, the captions will autocorrect on your Android phone.

Pick from over 70 languages and dialects to read accurate captions in the language that’s being spoken. Quickly switch between languages during bilingual conversations.

“Live Transcribe” is easy to use, anywhere you have a wifi or network connection. It’s free to download on over 1.8B Android devices operating with 5.0 Lollipop and up.

To start, simply use “Live Transcribe” anywhere, to have conversations with anyone.

We partnered with “Gallaudet University“, a premier school for the deaf and hard of hearing, to make sure that “Live Transcribe” was helpful for everyday use. Partners at Gallaudet helped with testing and improvements along the way.

Ready to get started?

This new Android Accessibility service is available to download as an app on the Google Play store. After installing the app, turn on Live Transcribe in your phone’s Accessibility settings and tap on the app to use it.

or

If you have a Pixel 3, simply turn on Live Transcribe in your Accessibility settings.

Have a question or want to share your feedback on “Live Transcribe”? Find answers to frequently asked questions in our Help Center or contact us via Google Accessibility support.

BOSE previewS NEW hearing aids

Bose Hearing Aids that are expected to be introduced for sale, look nearly identical to their last hearing-assistive product, the Bose “Hearphones”. (left below photo)The Bose Hearing Aid is the first FDA-approved hearing aid in a new category of products known as “self-fitting air-conduction hearing aids.” (right photo)

Bose Hearing Aid Hearphones

Right photo is FDA Filing): Bose Hearphones (Source – Hearphones User Manual)

Clinical findings

The FDA’s summary of the Bose hearing aid followed the October approval of the company’s “De Novo” application for the newhearing aid. In addition to providing a detailed description of the product, it says clinical findings demonstrate the Bose self-fitting hearing aid “provides performance benefit consistent with that of the same hearing aid fitted by hearing aid professionals.”

The Bose Hearing Aid provides performance benefits consistent with that of the same hearing aid fitted by hearing aid professionals for individuals ages 18 and older with mild to moderate hearing loss, according to the FDA Summary

New category of self-fitting hearing aids

According to the FDA, the Bose self-fitting hearing aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user’s hearing needs. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

A self-fitting air-conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings.FDA Summary

Although the latest FDA documentation clears the way for Bose to sell its new Hearing Aid, the company has not yet said when it plans to go to market.

Hearing-aid earbuds attached to a flexible neckband packed with electronics

The Bose Hearing Aid looks like the popular Bose Hearphones, with a flexible neckband housing a rechargeable lithium-ion battery and electronic components with extending cables for the right and left ears. Earbuds are connected to the neckband by flexible wires, with an ear-tip mounted on each earbud. Three sizes of tips are packaged with the product so that the user can choose the optimal size.

The Hearing Aid has two microphones in each earbud that may be configured in omnidirectional or directional modes to enhance understanding of speech in noise. Active noise reduction using “feedback and feedforward control loops” reduces environmental sounds, with power from a rechargeable 3.7 V, 250 mAh lithium-ion battery pack.

Like the Hearphones, the Bose Hearing Aid will feature Bluetooth audio streaming from smartphones, for both music and phone calls.

Self-fitting software with mobile “Bose Hear” smartphone app

The Bose Hear mobile smartphone app works with both iPhones and Android smartphones. Bose Hearphones users will find familiar device configurations including “World Volume” and “Treble/Bass” gain settings. The settings are preserved between use sessions and the settings from the previous session are recalled upon power-up of the device.

Bose Hear App

Screenshots from the Bose Hear App for Bose Hearphones

A set of manual buttons located on one of the cables from the neckband can also be used to adjust both the “World Volume” and directional mode.

Hearing Aid Features

Hearing aid signal processing includes 12-channel wide dynamic range compression amplification with compression thresholds fixed at speech-equivalent 52 decibels (dB) sound pressure level (SPL). Noise reduction is continuously active, lessening environmental noise and decreasing amplification of the user’s own voice.

Additional features include:

  • Feedback cancellation
  • Steady state noise reduction
  • Directionality (three modes controllable by user)
  • Impulse noise control
  • Left/Right balance
  • Bluetooth-compliant 2.4 GHz wireless radio for streaming audio, telephony, and control
  • Microphone array to help clarify voices on phone calls
  • Volume-optimized audio equalization (selectable high-frequency boost when listening to streamed content)
  • Voice prompts
  • Battery life of approximately 10 hours
  • NFC pairing for compatible Android devices

Clinical tests satisfy FDA that self-fitting software works

A human-factors study, non-clinical bench tests, and two clinical studies satisfied the FDA that the Bose Hearing Aid will be safely deliver on the promise of self-fitting software for people with mild-to-moderate hearing loss.

Among two groups of users, one with a professional fitting and one that used the self-fit software, the studies concluded that: Subjects in the self-fit group were satisfied with (or preferred) their own settings to the professionally-selected settings more than were/did subjects in the professionally fit group.

The subjects in the self-fit group rated themselves significantly happier with the sound quality than did those in the pro-fit group.

There was no difference in speech intelligibility benefit between the self-fit and pro-fit groups.

The report concludes that the clinical data support the claim that the Bose self-fitting hearing aid “provides performance benefit consistent with that of the same hearing aid fitted by hearing professionals for individuals ages 18 and older with mild to moderate hearing loss.”

Rechargeable hearing aid batteries

Rechargeable Hearing Aid batteries may be repeatedly charged and are typically charged every night to provide continual daily use. The daily battery life varies by battery size, chemistry, the amount of energy stored in the battery, the hearing aid programming,and the listening habits of the user. The batteries themselves will typically last as long as one year. There are 3 major types of rechargeable batteries.

Nickel metal hydride (NiMH) hearing aid batteries do not have sufficient energy to last a full day. In addition, they cannot be charged more than 300 times (i.e., cycle life) and, therefore, do not last a full year.

Silver-zinc  batteries offer greater daily and overall battery life than NiMH batteries. Silver-zinc batteries operate on a lower voltage,(1.6-1.7V) and are non-toxic and non-flammable, and there are fewer risks if swallowed or ingested by their family, or pets.

Lithium-ion batteries, on the other hand, operate at a higher voltage (3.6-3.7V) and do carry considerable risks related to flammability and toxicity. Due to these risks, lithium-ion batteries are sealed into the hearing aid case.

Disposable batteries as a backup

Silver-zinc rechargeable hearing aid batteries are often removable from the hearing aid case, and interchangeable with disposable zinc-air batteries. This provides flexibility to hearing aid users when they go “off the electric grid”, or there is a power outage and need to use disposable batteries temporarily. Forgetting to charge your hearing aid batteries is also less of a problem when disposables are available as a backup.

How long do rechargeable hearing aids last on a single charge?

Depending on the hearing aid model, and the number of hours of wireless streaming, the rechargeable batteries provide anywhere from 7.7 (with full time streaming) to 24.7 (without streaming) hours of use time. But, wireless streaming has a significant impact on how much life you can expect out of your hearing aid battery.

Four primary factors influence battery performance:

  1. Advanced features
  2. Wireless streaming
  3. Amount of amplification
  4. Battery current drain

Advanced features

Modern hearing aids employ a number of advanced features, which provide louder, cleaner, more comfortable sound. Technologies like noise suppression and feedback cancellation continuously monitor and process sound in the hearing aid built-in computer. This increases power consumption leading to higher battery drain. These features not only differ among the hearing aids but also by the hearing aid user.As an example, a person with a more pronounced hearing loss may require more feedback cancellation and result in a shorter battery life.

Wireless streaming

A significant amount of energy is used every time you stream audio from your smartphone, TV, iPad, or other wireless accessories. Wireless streaming also happens when your left and right hearing aids communicate with each other to exchange audio or data.

Amount of amplification

For those with more severe hearing loss this means more power consumption.  Also, if one ear has more hearing loss than the other ear, the battery life on the more impaired ear could be shorter.

Battery current drain refers to how fast the hearing aid drains power from the battery. Hearing aid manufacturers typically publish current drain figures for every new hearing aid they produce. When current drain is measured by the manufacturer, hearing aids are put into a “test mode,” which disables advanced features and wireless connectivity which under-states true battery drain in actual use.

Tips for charging your hearing aids

  • Rechargeable hearing aids should be charged every night to maximize battery life. If you charge the battery every other night, this will not help extend the battery life, and could lead to issues down the road. Silver-zinc chemistry must have the opportunity to recharge to full capacity every night to get the best performance from the battery.
  • Leave your hearing aids in the charger when they are not being worn. The charger will not overcharge the hearing aids and will ensure the batteries stay at full charge. Leave in the charger when not in use.
  • Do not unplug the charger while the hearing aids are inserted. If the charger is not receiving power, then the hearing aids will automatically be turned on. This will cause the hearing aids to turn on, and the batteries to begin discharging.
  • Remember, your hearing aids may take up to 7 hours to recharge fully, and the charging lights will turn from blinking to solid green when charging is complete.
Zpower Charger

Storing your hearing aids

  • Short term storage – If you don’t plan to wear your hearing aids for a few days,leave the hearing aids in the charger with the charger plugged in.
  • Long term storage  it’s best to remove the rechargeable batteries from your hearing aids and store them separately.

Hearing aids price & product development update

Hearing Aid merger will effect consumer price and product choices

How will the new Widex and Sivantos MERGER effect the hearing aid community? I will review some of the probabilities.

Usually, when two big companies combine in an industry that’s already highly concentrated, antitrust regulators are suspicious. It can mean less competition, higher prices, slower innovation, and weaker customer service.

But the hearing-aid industry is already in the midst of technology-driven economic change. New low-priced competitors are now challenging the Industry leaders by taking advantage of constant reductions in the costs of advanced hearing-aid technologies. And in the U.S., the “Over-The-Counter Hearing-Aid Act” Which deregulated hearing aid sales is expected to continue making it easy for new competitors to enter the retail market.

The largest Six hearing-aid manufacturers have already responded to increased competition by lowering prices for their entry-level products. At the same time, they have consolidated their leadership in the premium-priced high end of the market with a succession of new, high-tech innovations. And the profits from those high-end sales are helping them continue their traditional investments in hearing-technology improvements.

Widex and Sivantos MERGER should be able to compete more effectively at the entry level on price with affordable, high-quality products. And they will probably continue to compete with the other leading manufacturers to be first to develop and deliver the latest new products and technologies to high-end customers.

So consumers looking for the latest advancements in high priced hearing aids should be able to continue looking forward to a constant stream of innovation from the “Biggest Five Manufacturers,” including Widex/Sivantos. At the same time, they should continue seeing more moderate prices for entry-level custom hearing aids.

“Sivantos” was grown out of the former “Siemens”hearing-aid business in 2015 with backing from EQT Partners, a private equity firm funded by Sweden’s Wallenberg family. EQT is known as a patient investor that has said it’s committed to the company’s long-term growth.

“Widex” has been a family-owned company since its introduction decades ago and is known for its commitment to R&D and constant development. The merger should help meet Widex’s need for a stronger financial foundation to continue competing at both the high-end and entry level of the hearing-aid market.

So, hearing-aid sellers can expect continuity from their sales, supplier and support relationships. And professionals should look forward to more cutting-edge products and technologies coming from the combined company.

However there are countless uncertainties. Especially about how it will impact consumers and the professionals who depend on both companies.

For example, if there’s a big push to save money, consolidation of Home-office functions could impact the professionals who rely on consistent product and sales support from each company. The details will be revealed when the merger is finalized, in about one month

More important will be how the combined companies respond to competition from new market entrants. If Widex/Sivantos and the rest of the “Big Five” are able to compete successfully with new, lower-priced competitors while continuing to lead the industry in hearing-technology innovation, then everyone wins.

Bose Launches Self-Fitting Hearing Aids with FDA Approval

Bose Launches Self-Fitting Hearing Aids with FDA Approval

 October 05, 2018

Bose Small

Bose SoundSport Free wireless earphones.

The U.S. Food and Drug Administration, FDA today allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss).

This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider.

“Hearing loss is a significant public health issue, especially as individuals age,” said Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health.

“Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”

Approximately 37.5 million adults aged 18 and over report having some trouble hearing without a hearing aid, ranging from “a little trouble” to “deaf.” Hearing loss can be caused by aging, exposure to loud noises, certain medical conditions and other factors. Hearing loss may be permanent or temporary. Individuals with permanent hearing loss can use hearing aids to help them hear the speech and sounds around them better, enabling them to communicate more effectively with others.

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid. Air conduction hearing aids work by capturing sound vibrations through one or more microphones. The signal is processed, amplified, and played back through an earphone placed in the ear canal. Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a health care professional.

While users may fit, program and control the Bose Hearing Aid on their own, the device must comply with applicable federal and state laws regarding the sale of hearing aids, including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser. The FDA is in the process of drafting proposed regulations for a new category of over-the-counter hearing aids as required by the FDA Reauthorization Act of 2017.

In authorizing marketing of the Bose device, the FDA reviewed data from clinical studies of 125 patients, which demonstrated that outcomes with self-fitting of the Bose Hearing Aid are comparable on average to those with professional fitting of the same device with respect to the amount of amplification selected, speech in noise testing and overall benefit.

In addition, when participants self-fit the Bose Hearing Aid, they generally preferred those hearing aid settings over the professionally-selected settings. The Bose Hearing Aid has been labeled to inform the consumer when to consult a hearing health care professional.

The Bose Hearing Aid was reviewed under the FDA’s De Novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

The FDA granted marketing authorization of the Bose Hearing Aid device to Bose Corporation.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA

One app. Complete control.

The Bose Connect app gives you easy access to everything your product has to offer. Get tips, unlock product features and personalize your settings, so you can spend more time enjoying the music instead of setting it up.

Worried about losing an ear bud? Or both? Don’t worry; the Connect app is here for you. Enable the Find My Buds feature, so you can easily see where your buds were last connected. Follow the map and boom! Got ‘em.

Download on the App Store
Get it on Google Play

TRULY WIRELESS

Enjoy complete freedom of movement.

RELIABLE CONNECTIONS

They’re designed to maximize the strength and reliability of a wireless signal.

STAYS COMFORTABLE. STAYS PUT.

StayHear+ Sport tips are designed for comfort and stability.

VOLUME-OPTIMIZED EQ

For consistent performance at any volume.

WATER RESISTANT

IPX4 rating means these are earbuds that aren’t afraid of sweat or rain.

BATTERY & CASE

5 hours of battery. Place them in the protective case for safe-keeping and to recharge. The case provides 10 hours of battery.

SoundSport Free wireless headphones

30-day Risk Free Trial
Free expedited shipping and free return shipping
$199.95
IN STOCK
 

No Interest if paid in full in 6 months on purchases of $99+

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Everything you want to know about EarMolds