Not technically a hearing aid, but they can still help you hear
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In 2009, the FDA created a class of electronic devices called Personal Sound Amplification Products (PSAPs). These devices “are intended to amplify environmental sound for non-hearing impaired consumers.”1 The original products available in this class were very basic. However, over the years, the technical specs and developments of these products have made them very close to what will eventually become true OTC hearing aids. (See our article on OTC, or Over the Counter, hearing aids for more details).
I recently had the opportunity to review the Sona, the highest technology PSAP from Otofonix. This company was founded by a retired Otolaryngologist (ENT) who wanted to provide more affordable options for people with hearing loss. In this review, I'll cover everything you need to know about these devices, including costs, features, mobile apps, and how they stack up to the competition.
I was quite impressed with the overall build quality and packaging of Otofonix's devices. The Sona fits into the “Slim Tube BTE” category of hearing devices. This means that the electronics sit just behind the ear, and the amplified sound travels down a small, thin tube to a silicone “dome” in the ear canal. It's important to note that Otofonix currently only offers BTE devices, so if you're leaning towards an in-the-ear hearing aid, you'll want to search elsewhere. Below are the “unboxing” photos for a closer look.
Quick Tip: To learn more about the different styles of hearing aids from behind-the-ear to in-the-canal, visit our 2022 hearing aid buyers guide.
The Sona uses a #13 Zinc-Air battery and is comparable in size and build quality to most mid-level devices from the “Big Six” hearing aid manufacturers. The Sona costs $1,910 per pair. For comparison, Otofonix prices fall right into the mid-tier price range for the market; there are a few cheaper options out there, but they're still more affordable than most premium hearing aids.
Quick Tip: Check out our list of this year's best hearing aids to compare Otofonix to other top options.
The Sona's key features include Bluetooth compatibility, “adaptive” technology, and what they call customized hearing. These features will come in handy for seniors who want a device that can be controlled and adjusted from your phone.
After unboxing the devices, I installed the smartphone app and ran through the app-based hearing test, which is delivered through the PSAPs. I like this “in-situ” test because it takes the patient’s ear canal acoustics into account when testing. If you have results from a recent standard audiogram, you can also input them into the app.
The app provides a nice interface to adjust volume and select between the four preset programs (Conversation, Restaurant, Traffic, and Outdoor). These programs are designed to address the needs of the average user as they move throughout their day. Below are screen captures I took while using the app. Overall, I found that the app was straightforward, and my test results were easy to interpret.
In addition to the Sona, Otofonix offers the Groove ($1,910 per pair, the Helix ($1,110 per pair), the Encore ($990 per pair), the Elite ($710 per pair), and the Apex ($496 per pair). All models have directional microphones, noise reduction, and digital sound processors. The Encore and Helix models have a telecoil that allows users to access hearing loops and other inductance systems.
All Otofonix devices have a one-year warranty and a 45-day money-back return option. Hearing aids typically take some getting used to, so it's nice to have the warranty and return window. Their website provides a comprehensive FAQ page and a nice collection of captioned videos that address potential customers’ most common problems and questions. Users can purchase replacement domes, tubes, and batteries on their website as well.
Otofonix offers an additional protection plan for $9.95 per month, covering damages, but I could not see any coverage for loss on their site. This may not be a deal-breaker, but is something to consider, especially if you're known for misplacing your devices. No judgment here; we've all been there!
Since the Otofonix is technically not a hearing aid, it’s hard to compare head to head with the other products we review. Looking at the Sona I tested and the documentation on their website, I feel this is an administrative difference rather than a technical one. Legally, these devices are amplifiers (PSAPs), and the company is meticulous in its literature and videos to call them that. But from a functional and practical standpoint, they do all the things that we expect OTC hearing aids to do once the FDA gets around to defining them. If we look at the Otofonix like that, I feel comfortable comparing it to the entry-level to mid-range hearing aids offered five to ten years ago from major manufacturers.
This fact isn’t really a dig against Otofonix. Our understanding of hearing loss hasn’t changed that much in that period. We have a lot of new technology that improves the convenience and user experience, but not a lot of measurable improvement in hearing, especially for people who spend most of their time in quiet, not-too-complex listening settings. I wouldn’t recommend an Otofonix device for a senior still active on committees or working part-time. On the other hand, my aunt, for example, who is 90 and spends most of her time at home or visiting with one or two people at a time, would do great with them.
At the end of the day, Otofonix is worth a look, assuming you keep your expectations in line with what the product offers. I also see Otofonix as a great “gateway” device to give the right person a positive value experience with simple hearing improvement who will then “upgrade” to a more conventional hearing aid as they get back out into the world.
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FDA. (2009). Guidance for Industry and FDA Staff.