How an Israeli Startup Turns Standard Wireless Earbuds Into Hearing Aids
Israeli startup Tuned developed hardware-agnostic software that transforms standard consumer earbuds into FDA-compliant hearing aids, paving the way for audio brands globally.
Before tech giants Apple and Samsung secured FDA clearance to transform their earbuds into hearing aids, a small Israeli startup called Tuned entered the audio health space, developing a software-only solution designed to turn generic wireless earphones into FDA-compliant medical devices.
The Gamble That Paid Off
Founded in late 2020 by Ron Ganot, who serves as co-founder and Chief Business Officer (CBO), Tuned began its journey long before the U.S. Food and Drug Administration established the over-the-counter (OTC) hearing aid category in October 2022. Up until that regulatory shift, hearing aids were strictly medical devices that required professional fitting.
"It was a gamble," Ganot said in an interview. "Until 2022, a hearing aid in the U.S. was a product you could only sell through a professional. We started developing this before it was even clear such a category would exist."
Tuned operates on a software layer that sits directly on top of existing hardware chips inside commercial wireless earbuds. While Apple and Samsung offer hearing-enhancement features exclusive to their proprietary devices, Tuned is hardware-agnostic, partnering with third-party audio manufacturers.
Acoustic Calibration and AI Customization
Transforming standard earbuds into clinical-grade hearing aids involves complex acoustic processing. According to Ganot, standard consumer headphones already execute advanced audio processing for music and phone calls, but this processing is not calibrated to an individual's specific hearing profile.
Tuned's four-step software process begins with acoustic characterization. Because every earbud model features a distinct acoustic signature due to variations in speakers, microphones, and ear seals, Tuned calibrates each model beforehand. This ensures that when the software plays a sound at a specific volume, it precisely reaches the eardrum.
Next, the user performs an in-app hearing test directly through the earphones, evaluating each ear separately while monitoring background noise. This generates a clinical-grade audiogram without requiring physical audiologist equipment.
The core proprietary technology lies in the third step: a translation engine that maps the user's clinical prescription into parameters supported by specific hardware chips. This includes frequency-dependent amplification, compression ratios, output limits, and feedback suppression. Finally, an AI-powered conversational chatbot allows users to fine-tune their audio settings using natural language.
Hardware Requirements and Global Market Expansion
Tuned's software cannot run on just any device. It requires specific hardware prerequisites, including access to the earbud's chipset SDK, low latency, transparency mode, high-quality microphones, and sufficient battery life for daily use.
Following three years of rigorous clinical research, documentation, and regulatory validation, Tuned secured its first FDA clearance in late 2023, making it the second entity globally to receive regulatory approval for software-driven hearing amplification on consumer hardware.
Operating on a B2B model, Tuned licenses its platform to original equipment manufacturers (OEMs) and offers SaaS solutions for audiology clinics. Its technology is already integrated into JVC hearing device lines in the U.S. and is deployed through partnerships with major audio brands in Japan, alongside ongoing pilots with global hearing aid networks.
