• OTC hearing tech stack for faster, compliant, lower-cost launches

    Lyratone powers brands with full-stack, certified OTC hearing solutions—faster iteration, radically lower cost

  • Official FDA Definition: OTC Hearing Aid

    Under the U.S. Food and Drug Administration (FDA) final rule (effective October 2022), the definition of an Over-the-Counter (OTC) Hearing Aid is quite specific. It distinguishes these devices from prescription hearing aids by their intended use, technology, and user profile.

    Here is the detailed definition based on the regulatory text (21 CFR 800.30):

    An Over-the-Counter (OTC) Hearing Aid is a medical device that meets the following criteria:

    • Intended User: It is intended for use by adults (18 years of age or older) who have perceived mild to moderate hearing impairment.
    • Method of Sale: It is available to consumers without the supervision, prescription, or involvement of a licensed health care professional (such as an otolaryngologist or audiologist).
    • Technology & Control: It allows the user to control the device and customize it to their hearing needs. This may include:
      • Self-assessment tests for hearing loss.
      • Tools for frequency and gain customization.
      • Software or apps for user-driven adjustments.
    • Output Limits: To ensure safety without professional fitting, the FDA imposes strict acoustic performance limits:
      • General Limit: The output cannot exceed 111 dB SPL.
      • Input-Controlled Limit: If the device has activated input-controlled compression, the limit is 117 dB SPL.
    • Insertion Depth: The device must not be designed so that any part of it (other than a soft ear tip) extends into the bony portion of the ear canal.

  • The difference between OTC Hearing Aid, Prescription Hearing Aid and PSAP

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    OTC Hearing Aid

    • User Age: 18+ only
    • Hearing Loss Level: Mild to Moderate
    • FDA Class II Medical Device
    • Not Required Professional
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    Prescription Hearing Aid

    • All ages (including pediatric)
    • Mild to Profound
    • FDA Class I or II Medical Device
    • Licensed Professional
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    Personal Sound Amplifier

    • All ages
    • Not for hearing loss (non-medical)
    • Not a medical device
    • Not Required Professional

  • Lyratone's turnkey solution

    Lyratone delivers a medical-grade, full-stack, software/AI-defined hearing platform plus end-to-end engineering services that help global brands launch hearing products faster, customize more deeply, and keep improving via software updates at significantly lower cost.

    • Turnkey full stack: medical-grade algorithms (LyraOS), SoC-based hardware modules (LyraCore), multiple device form factors, and both consumer self-fitting + professional fitting tools.
    • Lifecycle services: design consulting (ID/structural acoustics), integration testing and algorithm tuning, and manufacturing + supply chain support.
    • Key differentiation: software-defined architecture decouples algorithms from hardware, enabling rapid customization and frequent OTA updates instead of slow hardware redesign cycles.
    • Stronger control & efficiency: 90%+ self-developed IP and mass-market SoC supply chains drive agility and reduce costs (claimed 1/3 to 1/5).
    • Core advantage: acts as a long-term tech enabler—products can continuously evolve through software so they don’t become obsolete.

  • OTC特色模块介绍

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    OTC Fitting and Tuning Modules

    Lyratone provides a medical-grade, automated fitting ecosystem tailored for the OTC (Over-the-Counter) market, enabling users to transition from unboxing to personalized hearing in minutes. This "Hearing as a Service" (HaaS) platform bridges the gap between complex clinical audiology and user-friendly consumer experiences.

    • Pure Tone Testing: The core of the fitting module is a high-precision Pure Tone Audiometry system that allows users to conduct a professional-grade hearing test using only their smartphone and the hearing device.
    • User-Centric Self-Tuning Modules: Once the initial fitting is complete, the module empowers users to fine-tune their auditory experience in real-time through an intuitive interface.
    • Advanced Customization & AI Support: Professional PC Suite and OTA Evolution.

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    High-Performance Bluetooth Module

    Our Bluetooth module is engineered to bridge the gap between medical-grade hearing assistance and modern consumer electronics.

    • Universal Compatibility (BT 5.3/5.4+): The module utilizes Bluetooth Classic version 5.3 and 5.4, providing robust, high-bandwidth connectivity with full support for both iOS and Android ecosystems.
    • Proprietary Communication Protocol: Beyond standard audio streaming, Lyratone employs a proprietary protocol for data exchange between the hearing aid and the smartphone. This dedicated link ensures secure and efficient transmission for real-time parameter adjustment, status reporting, and complex interactive fitting processes without interfering with audio quality.
    • All-Scenario Integration: Supports three-link audio processing, allowing users to switch seamlessly between face-to-face conversation, phone calls, and media streaming (such as music or short-form video) while maintaining full hearing compensation.
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    Intelligent Rechargeable Module

    Designed for the "always-on" lifestyle, our charging solution focuses on battery longevity, safety, and user transparency.

    • Smart Battery Monitoring: The module provides real-time battery level tracking, which is displayed directly within the smartphone app, allowing users to manage their usage effectively.
    • Advanced Battery Control: Integrated power management logic handles charging cycles, overcharge protection, and power-saving modes, ensuring the device remains safe and reliable throughout its lifespan.
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