← Product Code [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO) · K953814

# OTOSCAPE (K953814)

_Soundscape Technologies, Inc. · EWO · Dec 21, 1995 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K953814

## Device Facts

- **Applicant:** Soundscape Technologies, Inc.
- **Product Code:** [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO.md)
- **Decision Date:** Dec 21, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.1050
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

---

**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K953814](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K953814)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com