Phonak Lyric Hearing Aid Now FDA-Cleared for Self-replacement

Phonak has gained clearance from the US Food and Drug Administration (FDA) to offer patients who use Phonak Lyric a self-replacement option for the tiny in-canal device—the hearing industry’s only 100% invisible extended-wear hearing aid. With the new clearance, certified Lyric providers in the United States have the discretion to offer experienced Lyric wearers the ability to replace their devices independently, at least on some occasions. This new option should enhance accessibility and reduce the need for unnecessary in-office visits.

Michelle Wiebke, AuD, Senior Lyric Audiology and Education Manager told HearingTracker that self-replacement changes the Lyric subscription landscape for patients and providers by moving from required in-office replacement visits each time to office visits every other time, increasing convenience and adding flexibility and freedom. “Due to different regulations, self-replacement has been available for a couple years in other countries offering Lyric,” she says. “By engaging with FDA and earning clearance of self-replacement in the US, we are now able to bring self-replacement to the largest Lyric patient base in the world. We took care to ensure the clinical study for self-replacement was robust to achieve FDA clearance but also to support hearing care professionals who would ultimately offer and support their patients with the self-replacement procedure.”

Phonak notes that self-replacement is optional and not suitable for everyone; newer users and those with certain health issues or physical limitations may not have this option. Patients interested in incorporating self-replacement into their Lyric hearing experience are encouraged to schedule a consultation with their Lyric provider to discuss candidacy.

According to Phonak, key benefits of the self-replacement model include:

• Time-savings. Up to 50% fewer office visits can result from self-replacement.
• Flexibility. More flexible refitting alternatives for Lyric users to better meet their needs.
• Confidence. Patients can feel confident knowing they have replacement devices readily available, minimizing emergency calls and ensuring uninterrupted hearing.
• Attractiveness. Studies show that both non-hearing aid owners and current wearers are more likely to choose Lyric with self-replacement as an option.^1,2

A truly unique hearing solution…now with a more convenient replacement option

Phonak Lyric is a unique hearing aid unlike others offered on the market. It is inserted deeply in the ear canal by a trained and certified audiologist, hearing aid specialist, or otolaryngologist, where it can stay without needing to be removed until the battery wanes, which is usually around 2-3 months.

While there are several contraindications to its use, and it is not for everyone, many long-time Lyric users are fiercely loyal to the product. Due to its unique 24-7 nature, it is a favorite among parents of young children who want to hear at night, those who have trouble sleeping due to their tinnitus, and others who are just drawn to a truly invisible extended-wear hearing solution.

As the only disposable and analog hearing aid from a global manufacturer, it also requires no maintenance and is a favorite among musicians. (i.e., there are no batteries, domes, or wax guards to change, and it benefits from more natural, less-processed sound). Also, because Lyric relies on a subscription model, it ensures that patients get the latest updates at no additional charge.

However, as HearingTracker Audiologist Matthew Allsop points out in the above video, using the Lyric also necessitates making an office visit 4-6 times a year to replace the disposable device. With today’s announcement, this number of office visits could be halved; if you're cleared by your hearing care professional, you may change the Lyric yourself once every other insertion. It also means the Lyric provider can provide you with a replacement device, so it is readily available when your current Lyric starts to wane in power—minimizing emergency calls and ensuring uninterrupted hearing.

“Success with self-replacement hinges on the unique perspective experienced users [successfully wearing for 3+ months] have of the positioning and sound quality of the device placed in their ear,” says Wiebke. “Once they know Lyric can successfully reside in the ear following placement by the hearing care professional [HCP], they can replace devices, following training by the HCP, to almost the exact placement the HCP achieved by feel and sound quality alone.”

For more information about the Phonak Lyric Self-Replacement option, or to find a local Lyric provider, please visit the Phonak website.