Audiometric testing · equipment

Soundtrace Audiometer Specifications: Offline, Group and Ambient-Noise Capabilities

The Soundtrace Audiometer is an FDA-listed automated Type 4 audiometer for occupational hearing-conservation programs. It works online or offline, supports four routine and up to eight simultaneous testing stations, and documents ambient conditions with every test.

Soundtrace Audiometer

4 / 8 seats

routine / maximum

Class 2 ambient

continuous measurement

Independent 1910.95 Audit

Third-Party Reviewed

FDA Registered

Class II Medical Device

SOC 2 Type II

AICPA Certified

HIPAA Compliant

Powered by Vanta

Made in USA

Engineered & Built

~6 min
Typical test duration
4 / 8
Routine / maximum seats
Offline
Automatic reconnection sync
Class 2
Integrated ambient measurement

Soundtrace Audiometer at a glance

The details behind the testing experience.

Designed to be clear for EHS leaders, and specific enough for clinical, procurement, and IT reviews.

Device
Soundtrace automated microprocessor Type 4 pure-tone air-conduction audiometer
FDA device classification and listing
FDA-registered and listed Class II medical device under 21 CFR 874.1050; product code EWO
ANSI S3.6 classification
Meets ANSI/ASA S3.6-2018 (R2023) requirements for a Type 4 audiometer
Test frequencies and output
500, 1000, 2000, 3000, 4000, 6000, and 8000 Hz; frequency-specific output range up to 100 dB HL
Group capacity
One facilitator routinely supervises four simultaneous tests from a shared dashboard; two facilitators can support eight stations in one testing area
Group throughput
Approximately 20 or more completed audiograms per hour with one facilitator; 40–48 per hour with two facilitators under typical conditions
Offline functionality
Tests run without an internet connection and sync automatically after reconnection
Connectivity and power
Bluetooth and USB connectivity; USB-C powered with optional battery operation of approximately 12 hours
Typical test duration
Approximately six minutes per employee
Response-button design
Dedicated, single-purpose handheld response button
Headset and attenuation
RadioEar DD65v2 medical-grade circumaural headset with high attenuation
Ambient limits
ANSI Basic mode and ANSI Advanced mode use one established ambient-noise cap for simple, consistent operation.
Ambient measurement
Integrated, calibrated Class 2 ambient measurement system
Threshold-linked ambient record
Ambient noise can be viewed alongside each recorded hearing threshold, while routine testing uses a single established ambient-noise cap.
Automatic pausing and event records
Testing automatically pauses when the established ambient-noise cap is exceeded and resumes when conditions are acceptable; noise and testing events are retained with the record.
Capabilities
Pure-tone audiometry and REAT hearing-protection fit testing

Verify Soundtrace in the FDA Registration & Listing Database.

Invisible Booth™ ambient intelligence

A test that knows when to wait.

The Soundtrace Audiometer continuously observes the room while testing is in progress. One established ambient-noise cap keeps operation simple: the test pauses when the cap is exceeded and resumes when conditions improve. For documentation, ambient noise can be reviewed alongside each recorded hearing threshold.

Measure

Calibrated Class 2 ambient system.

Pause

Automatic pause and resume behavior.

Document

Noise and testing events retained.

Audiometric testing in progress with Soundtrace

Operationally ready

Built for the day your crew actually has.

  • Dedicated response control keeps the test interaction simple.
  • Bluetooth and USB support flexible, field-ready setups.
  • HIPAA and SOC 2 Type II workflows carry the record beyond the test.
Explore audiometric testing

Annual calibration

Calibrated before deployment. Replaced before expiration.

Soundtrace manages calibration from start to finish. Each Soundtrace Audiometer and its paired RadioEar DD65v2 headset receives a full electroacoustic calibration before deployment and annually thereafter under ANSI/ASA S3.6. This annual cadence exceeds OSHA’s minimum requirement for exhaustive calibration every two years.

What is verified

Frequency accuracy, hearing-level output, linearity, harmonic distortion, crosstalk, and on/off performance for both channels from 500 through 8000 Hz.

How it is documented

Testing uses traceable Larson Davis equipment and an acoustic ear coupler. The integrated Class 2 ambient system is calibrated and documented separately.

How downtime is avoided

Approximately two weeks before expiration, Soundtrace sends a freshly calibrated replacement so testing can continue without interruption.

Soundtrace application showing an audiometer's calibration date, calibration record, and calibration report

Calibration status stays attached to the device.

Teams can see the relevant calibration date and open the calibration record or report directly from the audiometer details in Soundtrace.

No-downtime exchange

The replacement arrives before the current calibration expires.

1. Freshly calibrated equipment ships

Soundtrace sends a replacement audiometer and paired headset approximately two weeks before expiration.

2. Your team makes a simple swap

Put the fresh unit into service and continue testing—no calibration appointment or program interruption.

3. The expiring equipment returns

Return the previous unit after the replacement is operating. Your site is never left without an audiometer.

Continuous testing availability

The overlap between delivery and expiration keeps annual calibration from becoming a scheduling disruption.

Calibration and quality-assurance work is performed at Soundtrace’s Cincinnati office. Device-history records are maintained within Soundtrace’s FDA-regulated quality management system under 21 CFR Part 820 (QMSR) and are available upon request.

Evidence supporting Soundtrace audiometry

Performance claims with the evidence beside them.

Field agreement, implementation speed, and compliance architecture are documented separately so technical reviewers can examine the basis for each claim.

9,496

Real-world matched comparisons

91.4% were within ±10 dB, with an average paired difference of −2.68 dB across the untrimmed primary population. This measures real-world agreement, not controlled clinical accuracy.

Review the field study

~6 min

Purdue implementation result

Purdue University’s program reduced average testing time from roughly 30 minutes to approximately six minutes after adopting Soundtrace’s testing and workflow model.

Read the Purdue evidence

29 CFR 1910.95

Independent program review

Soundtrace’s hearing-conservation program architecture has been independently evaluated against OSHA’s occupational-noise requirements.

See why teams trust Soundtrace

Beyond the test

The accurate audiogram is the starting point.

After synchronization, each audiogram becomes part of the employee’s longitudinal Soundtrace record. The platform compares it with the appropriate baseline, identifies possible threshold shifts, routes the result for professional review, and generates required documentation.

The result stays connected to exposure, hearing-protection, notification, and follow-up workflows—so the equipment and the hearing-conservation program share one record.

Explore hearing-conservation recordkeeping

Frequently asked questions

Practical questions, documented answers.

Technical, operational, calibration, and program questions about Soundtrace audiometry.

The Soundtrace Audiometer is an FDA-listed, automated Type 4 pure-tone audiometer designed for occupational hearing-conservation programs. It supports online and offline testing, group testing, real-time Class 2 ambient-noise measurement, automated threshold identification, and REAT hearing-protection fit testing.

See the Soundtrace Audiometer in your program.

Bring your room, shift, and workforce questions. We’ll walk through the equipment and workflow together.

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