In the world of hearing aids, we are always looking for ways to improve or enhance the client experience. This doesn’t have to be purely about how well someone hears but could be related to how easy a hearing aid is to use, or how it is paid for. Things that we may not always consider but could be argued to be equally or more important are things like reassurance, attractiveness of a product with regards to how it meets some ones’ needs, time it takes to maintain and independence, to name but a few.
So before we introduce something new, we have to look at it across as many different parameters as possible to make sure we end up delivering something that people really want as well as making sure it is effective.
Lyric™ is an extended wear hearing aid that sits in the ear for months at a time. When it stops working it can be removed by the client or they can get it removed by their certified Lyric provider. A new working device is then placed in the ear canal but now this replacement is always performed by the provider. Over the past few years, some Lyric providers and clients have asked if it would be possible to have the client be allowed to replace their Lyric themselves.
The Phonak Lyric team decided to investigate this ‘self-replacement’ option in detail to find out whether it was worth pursuing.
We focused on three main areas
- Market Insight: Opinions of hearing care professionals (HCPs), hearing aid owners and non-hearing aid owners
- Clinical: Effectiveness and usability
- Regulatory pathways: Documentation required to obtain approval from regulatory bodies
In 2017, an online survey was conducted with 608 people split into 204 owners and 404 non-owners of hearing aids.1 The results of the survey showed that having a 100% invisible hearing aid is still a very attractive option compared to daily wear styles of hearing aids. In addition to this, when given the option of being able to self-replace a Lyric device in combination with 100% invisibility the attractiveness of this offering increases, and in the case of existing hearing aid owners, this attractiveness doubles.
In the same market survey, HCPs who fit Lyric were interviewed and asked about the challenges they saw with Lyric today. The HCPs mentioned that the unscheduled appointments (drop ins) and the frequency of appointments meant that they felt their productivity was reduced.
This feedback indicated to us that self-replacement could be an option, that if introduced, could address some of these issues while being an attractive proposition for the HCP and their clients.
Effectiveness of self-replacement is the most important consideration when introducing a new procedure to the HCPs and their clients. A clinical study looking at client safety, device efficacy and client perception was conducted. Alongside this, usability studies looking at the effectiveness of the training material and methodology were also performed.
Results of the clinical study showed there was no more ear health issues observed in the self-replacement group compared to the control group and no significant difference in the insertion depth of the device.²
Phonak has always provided the guidance that Lyric should only be replaced by an HCP who has been certified to fit Lyric. Self-replacement is a procedure that the HCP will oversee so they will have to assess if their client is suitable to replace their own Lyric every second appointment. The whole process is being fully assessed by the regulatory bodies around the world to make sure that all the guidance and tools offered with the procedure do not introduce unnecessary risk.
This approval process has been a learning curve and a lot of work for the whole team but this is coming to fruition as we have already satisfied the regulatory body that issues the CE mark to be able to launch the procedure in Europe. We are also working with the FDA to be able to launch in the US in the near future.
So what started as a few requests from around the world has resulted in a new attractive option for Lyric end users. This procedure is controlled and offers HCPs benefits such as reducing the frequency of in clinic visits, while also having an additional option for Lyric to offer your clients.
To learn more about Lyric, we invite you to visit phonakpro.com.
¹ Leibundgut, M (2017). Market Research ID #1054, please contact firstname.lastname@example.org if you are interested in more information.
² Gardner-Branson, G. (2020). Lyric self-replacement: safety, efficacy and precision. Phonak Field Study News. Retrieved from www.phonakpro.com/evidence, accessed February 09, 2021.