Echo Hear - AI Audiologist for Clinical Diagnostics

Why Now

The window just opened.

AI is ready

Adaptive Bayesian models can now run a reliable, clinical-grade hearing test without a specialist managing each tone.

FDA is ready

The FDA has authorized 1,450+ AI/ML medical devices — a record 295 in 2025 alone, most in diagnostics. The regulatory pathway is proven.

FDA AI-Enabled Medical Device List

Clinics are short-staffed

Every clinic is capacity-capped by specialist hours. 44% of US audiology facilities already have more open roles than candidates — the booth-bound model cannot stretch to meet demand.

ASHA Audiology Survey, 2023

Demand is exploding

1.5 billion people live with hearing loss today, rising to 2.5 billion by 2050. Aging, noise exposure, and earlier diagnosis awareness are accelerating the need for diagnostics.

WHO World Report on Hearing

AI made it possible. The FDA made it cleared. The workforce gap made it urgent.

The Pain

A structural access crisis — at scale.

75%

of U.S. counties are designated hearing health shortage areas

HRSA

1:100K

Audiologist-to-patient ratio in shortage areas

ASHA

62%

of physicians name administrative overload as the #1 driver of burnout

Medscape, 2024

~$50K

Minimum cost of the soundproof booth required for each diagnostic today

1 in 7 Americans lives with hearing loss.
Some providers have patients — not enough audiologists. Others have audiologists — not enough patients.
Echo Hear solves both.

Clinical Validation

Validated where it counts.

Assuta Samson Medical Center

Ashdod, Israel

Phase 1 clinical trial currently in execution. Booth-less diagnostic audiometry protocol under clinical supervision.

University of Pennsylvania

Philadelphia, USA

Phase 2 US validation partner.

Compliance Architecture

Built to the highest clinical standards

Echo Hear is architected from the ground up to meet and exceed the regulatory and security requirements of institutional healthcare partners.

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HIPAA-Aligned

Architecture designed to meet HIPAA requirements for patient health data from Phase 1.

In progress

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FDA 510(k)-Exempt

Echo Hear Phase 1 is classified as 510(k)-exempt under FDA product code EWO. Phase 2 proprietary hardware follows a De Novo pathway.

Phase 2: De Novo

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ISO 13485

Quality management system framework built to ISO 13485 medical device standards.

Roadmap

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SOC 2 Type II

Full SOC 2 Type II and ISO 27001 security posture targeted for Phase 2 connected platform.

Phase 2

Team

Clinical credibility. Operational execution.

Built for this specific problem — not assembled after the fact.

Meet the team →

Raise

Currently raising.

Echo Hear is in an active pre-seed fundraising process.

If you are a fund or angel investor and would like to learn more, reach out directly.

[email protected] →