Bose just introduced FDA-cleared, direct-to-consumer hearing aids for adults with mild to moderate hearing loss.

Users can use a smartphone app to fit, program and control a SoundControl hearing aid without a doctor visit, hearing test or prescription, according to Framingham, Mass.-based Bose. Each hearing aid will retail for $849.95 starting May 18th in five states: Massachusetts, Montana, North Carolina, South Carolina, and Texas, with nationwide availability to follow.

Wearers can also make setting adjustments themselves, in real-time and real-world environments, without assistance from a healthcare professional, the company added.

Bose scientists, audiologists and engineers designed the new hearing aid using over 30 years of research in mobile audio, mobile sound management and advanced data science, according to a news release. It was designed to make speech that once sounded mumbled — especially consonant sounds — clearer, softer voices better heard and understood, and following and joining conversations easier, even in noisy environments.

The app has a “focus” feature to help with communication or specific surroundings. Users can choose the “front” setting to zone in on conversations or the “everywhere” setting to hear sounds all around. They can preset the hearing aids for particular activities and places.

In a clinical study with researchers at Northwestern University, Bose CustomTune technology yielded results that were as good if not better than those achieved by traditional prescription-fitting methods used by audiologists, according to the company. The study’s participants were split into two groups with similar levels of hearing loss. One group used Bose CustomTune technology to self-tune a device, the other had the same device fit and tuned by an audiologist. Participants using Bose CustomTune technology reported being more satisfied with their sound quality than those whose devices were tuned by a hearing health professional.

The hearing aids have a behind-the-ear, receiver-in-canal design. Each weighs 3 grams and contains two microphones, one tiny speaker, and a standard 312 zinc-air battery. One lasts up to four days when used 14 hours daily. SoundControl hearing aids are compatible with iOS and Android devices and are eligible for FSA and HSA reimbursement.

“In the United States alone, approximately 48 million people suffer from some degree of hearing loss that interferes with their life. But the cost and complexity of treatment have become major barriers to getting help,” said Brian Maguire, category director of Bose Hear, in the release. “The Bose Hear app lets owners set up and customize their SoundControl hearing aids from home — in less than an hour — to reconnect with the moments that matter. That’s an amazing advancement the industry has been missing and nothing short of a breakthrough.”