Bose self-fitting hearing aids are finally here (Bose SoundControl™)

@eek said:

Does anyone have any information, or informed thoughts, about when these or other OTC aids might be available more widely in the U.S.? I understand (a little) about the FTC and possible Preemption of state laws, but it doesn’t look like the FTC has acted on the FDA Reauthorization Act at all yet. If I’m reading right, Bose found a workaround in the De Novo approval, rather than anything that would let them distribute the SoundControls more widely.

Since I’ve been posted so many times here, let’s assume for a minute that I’m not full of crap and that my experience with Bose HA is good. I bought these even though they clearly warned me that my hearing loss should preclude me from using them. The OTC Hearing Aid Act, which I’m sure most of you are familiar with states:
•Makes certain types of hearing aids –those intended to be used by adults to compensate for perceived mild to moderate hearing impairment–available over the counter.
•Removes an unnecessary and burdensome requirement that consumers obtain a medical evaluation or sign a waiver of that examination in order to obtain an OTC hearing aid.

So anyone that comes out with a product in this category can’t claim that they do more than allowed by law, even if they do exceed that performance. In fact, Bose uses the exact same language as the law. As this law was passed in 2017, it’s taken almost 4 years for them to bring them to market which could be because it was difficult for a variety of reasons including political ones. From what I’ve read, you are correct about the De Novo approval and that Bose had a lot of difficulty getting approval. Why is it so difficult? Bose is in business to make money and I don’t think they are taking a pot shot on a product like this, which if successful, could be more profitable than all their other products. They’ve invested too much money to not be sure that they can be successful. I’ve watched for their product release for almost 3 years now and it seemed like it happened suddenly. Almost like there is a window of opportunity, lets do it before it closes. Strictly my impression. These are just my guesses, that they need to proceed cautiously to not get shut down, they need to have quick and measurable success. They need to have enough product, parts and support. It is a weird roll out, but like anything, once you have a precedent, it’s a lot easier to gain momentum. I saw a commercial for a company called Lively HA last night and I checked their website and it’s a fairly similar business model. They OTC HA online but they have audiologists on remote call. The horse is out of the barn. It’s way interesting to see how it all shakes out. I don’t think this is going away.

Bose snuck through from their prior approval of another device as a medical device. They are not selling these under the OTC hearing aid legislation as the FDA has still not released a final rule for the regulation of OTC aids. DTC are sold because there is a licensed audiologist in the sales process (however much or little they are). Everything else is a personal amplifier (PSAP) devices, not hearing aids in any classic sense, they just amplify everything. Until the FDA finalizes their rule by which to approve “true” OTC aids there will be nothing else released unless the manufacturer has some loophole they can rely on.

Is it legal to reply to yourself, as this young fella @MDB did in the post to which I am replying ?!

@kjp111 said:

I bought these even though they clearly warned me that my hearing loss should preclude me from using them.

But if you loss was actually a true severe loss, these Bose aids would be underpowered for you.
Like @AbramBaileyAuD said, you likely don’t have a true severe loss, likely just the last high frequencies are close to severe.

Civility costs nothing @kjp111, you may be frustrated at some of the forum members replies, but many are old hands on here, and go out of their way to help fellow HOH members…… @Zebras is a most helpful lady whom falls into this category! Nobody is actually accusing you of telling lies, your opinion is your own experience, but in the absence of a current audiogram they cannot make a valid comparison, and will therefore have to await other “Bose” new users, to post up, to ascertain if these may or may not meet their loss? They would be absolutely useless for me, being in the severe/profound threshold, so I have little or no interest in them for myself, but for others whom could benefit from these Bose Aids, they may be a godsend! I am truthfully glad you have found these Bose Aids highly beneficial, and hopefully many other HOH will be likewise…… Cheers Kev

It is not your imagination. I’m not posting here anymore about my experiences as it is clear the “regulars” here do not approve. I’m sure others have found this forum\thread and will never post their experiences. Such is the internet. FYI, 5 days and very happy with the Bose.

That’s a very sweeping statement statement @Fig would you care to elaborate? I am 100 percent in favour of cheaper options for those who may be financially challenged, and can’t afford to go to a regular AuD or indeed Costco, in my book any hearing aids, are better than none at all…… But, it’s no big deal to stick up your Audiogram to let other’s make a constructive assessment in comparison to their own loss…… Is there a trial period with these Bose Aids, or do you have to sign a waver if they recommend they aren’t for your loss? Does this mean you can’t return them if they recommend you not to buy? I am also glad you are doing well with them

@MDB You know what they say: it’s one thing to talk to yourself, but you are in real trouble when you start answering yourself!

It’s wonderful to read about it. I was really very concerned that only people with mild to moderate hearing loss would be able to use these devices.

Thank you for posting your opinion.

Hey Fig, How are you liking them. I’m 10 days and a full work week and I’m loving them. I closed over $600,000 worth of new business this past week and a big part of it has been that I can hear and negotiate with confidence. I feel like at this point that unless I suffer some major deterioration in my hearing in the next few years that these HA will be a permanent solution for me.

I went to the pharmacy drive through this morning to pick up a prescription. Every time the clerk said something to me, my girlfriend repeated it to me. I turned to her and said “Anne, I can hear everything she’s saying” She’s been my interpreter even with or without HA for years. I think I’m going to be good on my own. It’s nice to not have to be embarrassed because I am constantly turning to her and asking what they just said. And then hope that I can hear her telling me what they just said.

The 3 things I like so much about the Hearphones, compared to my RX hearing aids were:

• the focus (narrow/front/everywhere) works so well in noisy places.
• the mute is great; it really cuts out things like lawnmowers and leaf blowers.
• the response of the controls is very very fast. When I use my hearing aids somewhere I want to quickly go between very loud and very quiet, it takes 8 seconds, and I can’t hear anything during that time. The Hearphones are much faster, and they don’t pause and beep with each level.

Can anyone wearing the SoundControls comment on those aspects?

I can say the focus works extremely well. You can really tell when you turn it on as the sounds around you fade and the person in front of you that you’re speaking with comes thru much better. Great at restaurants and similar environments.

I don’t know about mute, the controls are virtually instant.

So are you saying that, if you are talking to a person, and there are other noises around, they are completely blanked out and you only hear the person talking? Did I get it right? Or do the surrounding sounds continue to be heard but in a more subdued way?