On September 12, 2024, the U.S. FDA officially approved Apple Inc.'s AirPods Pro headphones as an OTC (Over-The-Counter) hearing aid product (Figure 1). This marks a significant milestone in the hearing aid industry. The importance lies in two aspects: firstly, one of the world's largest consumer audio manufacturers has entered the hearing aid market, and secondly, Apple has achieved hearing aid functionality through software. Apple's software is named the Hearing Aid Feature. Here, we analyze the impact of Apple's entry into the hearing aid industry on the entire sector.
The impact of AirPods Pro 2's Hearing Aid Feature on the hearing aid industry is mainly discussed from two aspects: the market side and the product development side.
I. Market Side
From a market perspective, the entry of more new manufacturers indicates a continued optimism for the hearing aid market and signifies that this market is poised for rapid growth.
1. More new manufacturers will enter the hearing aid industry. Apple, as an industry benchmark, is regarded as a weathervane by many consumer electronics manufacturers in the global market. Particularly, some of Apple's major competitors have always used Apple as a benchmark, and Apple's entry will accelerate the speed at which these large manufacturers enter the hearing aid market.
2. The market of the existing top 5 hearing aid manufacturers will be affected. The top 5 international hearing aid manufacturers have been very slow in their actions regarding OTC hearing aid products since the FDA officially released the OTC act in October 2022. At most, they have collaborated with companies like Widex and Sony to release an OTC product into the market, and even then, under Sony's name. However, in terms of their own product layout, they have not shown much positive response to OTC products. Apple's entry, although not directly competing with the prescription hearing aid products of the top 5 manufacturers, will directly promote companies with hearing aid R&D capabilities to accelerate their entry into the prescription hearing aid market, thereby competing with the top 5 hearing aid manufacturers.
In summary, Apple's entry into the hearing aid market has two major impacts: firstly, Apple's entry is a recognition of the hearing aid market, which will guide more manufacturers to enter the market and promote its development. Secondly, for products, it raises the market's requirements for products, as Apple's products are a benchmark for all.
II. Product Development Side
The capability of a product is most fundamentally based on its foundation, which is technological capability. One of the most important milestones for Apple in this instance is the realization of hearing aid functionality through software. Apple's software, named the Hearing Aid Feature, can empower AirPod Pro headphones to function as a hearing aid. Its significance lies in the fact that the hearing aid functionality is realized through software, not the traditional hardware approach. We know that traditional hearing aids use ASIC (Application Specific Integrated Circuit) dedicated hearing aid chips, such as the top 5 hearing aid manufacturers and products based on Onsemi chips. Among international large-brand merchants, Apple is the first company to realize hearing aid functionality through software. This is also the innovative Software-Defined Hearing (SDH) approach in the hearing aid industry in recent years, where hearing aid functionality is realized through software.
III. Software-Defined Hearing
Under the framework of Software-Defined Hearing, the functionality of hearing aids is realized through software, replacing the original ASIC hardware approach. The biggest advantage of Software-Defined Hearing is the rapid iteration of products and open integration. In terms of products, it allows users to experience continuous updates and the best experiences of product functions in a short period.
Lyratone Technologies, Inc. pioneered the framework and practice of Software-Defined Hearing in the global hearing aid industry. Lyratone Technologies is a company focused on the R&D of medical-grade hearing aid technology. As early as the beginning of 2018, when the company was established, it embarked on a new R&D path for Software-Defined Hearing. Currently, the company focuses on 2B services, with products including hearing aid algorithms, PCBA mainboards, complete hearing aid units, and fitting software, forming a full-stack hearing aid platform technology. Lyratone has already launched various solutions for enterprise customers, including air conduction hearing aids, bone conduction hearing aids, and new types of open ear (OWS) hearing aids.
Apple's launch of its first hearing aid product through the Hearing Aid Feature software also fully endorses and substantiates Software-Defined Hearing as the technical and product development direction for a new generation of hearing aids.
Appendix: U.S. FDA Authorizes First Over-The-Counter Hearing Aid Software
https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid