Smart Diagnostic Devices

What Smart Diagnostic Devices does

Smart Diagnostic Devices is a privately-held medical device company founded in 2010 and headquartered in Eden Prairie, Minnesota, that designs, manufactures, and sells audiometric equipment for the occupational health market. Its core product is the SMART TONE Automatic Audiometer, a portable touch-screen device with an intuitive icon-based interface that enables hearing conservation screenings compliant with OSHA, MSHA, DOT, and FAA requirements, as well as ANSI S3.6 audiometer specifications. The company also produces the D-Check Bio-Acoustic Simulator for daily calibration verification of the audiometer, a thermal printer line, and replacement accessories (headsets, cables, ear cushions, power supplies). The combined hardware-software ecosystem is rounded out by SmartMove Cloud, a HIPAA-compliant cloud-based database launched in 2016 that stores audiometric and subject data, automatically calculates Standard Threshold Shift (STS), and generates compliance reports.

Name

Smart Diagnostic Devices

Legal name

Smart Diagnostic Devices

Website

https://smartdiagnosticdevices.com

Company type

Private

Founded year

2010

Operating status

Operating

Headcount range

11–50 employees

Short description

Smart Diagnostic Devices is a Minnesota-based medical device company that manufactures touch-screen audiometers and a HIPAA-compliant cloud data platform for occupational health professionals conducting hearing conservation screenings.

Ownership category

akta.pro rank

Product category

Occupational Health Audiometric Equipment

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL)

akta.pro secondary industry

Remote Diagnostics & Point-of-Care (Connected Testing, Home Lab Devices) (HLACAPAK)

Keywords

• Occupational audiometry equipment
• Hearing screening devices
• Audiometric data management
• Bio-acoustic calibration simulators
• Cloud hearing conservation

Headquarters

HQ city

Minneapolis

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Hardware Sales - SMART TONE Audiometer: One-time sale of SMART TONE Automatic Audiometer packages ranging from $2,406 to $3,648. Packages include various combinations of cloud subscription, D-Check simulator, printer, and paper
2. Hardware Sales - Accessories: Sale of replacement and accessory parts including D-Check Bio-Acoustic Simulator ($560), TDH-39 Headset ($1,029.24), thermal printers ($630), ear cushions ($39.96), power supplies, cables, and paper
3. SmartMove Cloud Subscriptions: Monthly subscription services for cloud data management: SmartMove Cloud at $19.95/month (2,500 subjects), SmartMove Cloud Premium at $64.95/month (includes additional features and storage). SmartMove Cloud Free included free with SMART TONE purchase (300 subjects)
4. Prepaid Cloud Subscriptions: Prepaid multi-year cloud subscriptions (Cloud 24 and Cloud 60) purchased through dealers. Monthly equivalent of $18.54 (Cloud 24) and $16.58 (Cloud 60) when upgraded to Premium

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels5 records

Core offering

Smart Diagnostic Devices manufactures and sells the SMART TONE Automatic Audiometer, a portable touch-screen audiometer for occupational health hearing conservation screenings, along with the D-Check Bio-Acoustic Simulator for daily calibration. The company also operates SmartMove Cloud, a HIPAA compliant cloud-based platform for storing, transferring, and managing audiometric and subject data, offered via subscription tiers.

Product overview

Smart Diagnostic Devices offers a portfolio of occupational health audiometer products centered around the SMART TONE Automatic Audiometer platform and the SmartMove Cloud cloud-based data management system. The core offering is the SMART TONE Automatic Audiometer—a portable touch-screen device for hearing conservation screenings—paired with the SmartMove Cloud platform (available in Free, Standard, and Premium tiers) for HIPAA compliant cloud storage, STS calculation, and audiometric data management. Supporting products include the D-Check Bio-Acoustic Simulator for daily calibration verification, various accessories (headsets, cables, power supplies, ear cushions), and thermal printing solutions. The products are designed to help occupational health professionals meet OSHA, MSHA, DOT, and FAA hearing program requirements.

Differentiator

Problem solved

Functional benefit

Brands

• SmartMove Cloud: HIPAA compliant cloud-based database and data management platform for audiometric and subject data, offering subscription plans for storage, STS calculation, and reporting.

Products and services

• SMART TONE Automatic Audiometer A portable touch-screen audiometer for occupational health professionals that delivers quick and accurate audiograms via an easy-touch touchscreen with an intuitive icon interface. Features automatic testing, storage, printing, transfer, and a built-in talk-over microphone. Compliant with ANSI S3.6 and OSHA 1910.95.
• SmartMove Cloud A HIPAA compliant cloud-based database platform for audiometric and subject data management, storage, and transfer. Provides online access to hearing test data from anywhere with internet connectivity and supports data transfer from SMART TONE and Tremetrics RA500 audiometers.
• D-Check Bio-Acoustic Simulator Quick and accurate daily calibration check device for the SMART TONE audiometer. Uses no batteries — power is supplied by the audiometer. Features color-coded ear cups and can be used table-top or test booth wall-mounted. Supports OSHA, MSHA, and DOT hearing programs.
• DPU-S245 Thermal Printer A proven, reliable 4-inch portable direct thermal printer with serial and parallel connectivity options. RoHS compliant printing solution for audiogram reports.
• TDH-39 Headset Replacement TDH-39 headset for the SMART TONE Automatic Audiometer with standard frequencies from 125 to 8000 Hz, featuring rubber red and blue ear cushions to distinguish right and left ears.
• SmartMove Cloud Premium Premium tier of SmartMove Cloud at $64.95/month providing access to 2 user profiles (with option to add more), STS analysis, import/export capabilities, 8 unique PDF report options, automatic baseline revision with override capabilities, expanded storage for 2,500+ subjects and audiograms, history questionnaire, administrative controls, additional data fields, and audiogram analysis.

Quantifiable outcome

• Eliminates manual STS calculations from thermal paper printouts
• +2 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature5 records

Partnerships

One partnership is on record.

• TremetricscoreTechnology or IntegrationSmartMove Cloud supports data transfer from Tremetrics RA500 audiometer in addition to SMART TONE audiometer, expanding data integration capabilities.

Scale indicators2 records

Recent moves6 records

Expansion highlights3 records

Emerging players

• Inventis: Inventis manufactures audiometers and diagnostic hearing devices with a focus on balancing clinical functionality and price. It is a smaller European player with overlapping occupational and clinical screening use cases.
• Audioscan: Audioscan manufactures hearing instrument verification and fitting equipment. While not a direct audiometer peer, it operates in adjacent diagnostic audiometric equipment markets with similar occupational and clinical customer segments.
• Otovation: Otovation is a smaller specialty manufacturer of portable audiometers and otoacoustic emission devices used in occupational health screening, partial overlap with Smart Diagnostic Devices' product scope.

Direct peers

• Interacoustics: Interacoustics designs and manufactures audiometers, tympanometers, and hearing assessment equipment for clinical and occupational health markets. It is also a Demant subsidiary and directly competes with Smart Diagnostic Devices in audiometric screening hardware.
• MedRx: MedRx (a Demant subsidiary) manufactures diagnostic audiometers and hearing assessment equipment marketed to audiologists and occupational health providers, competing directly with the SMART TONE platform.
• MAICO Diagnostics: MAICO Diagnostics is a direct competitor manufacturing audiometers and screening devices for occupational health and clinical use. It is a subsidiary of Demant, the same group whose email domain handles Smart Diagnostic Devices' privacy requests, making it the most directly comparable peer.
• Grason-Stadler (GSI): GSI is a long-established manufacturer of clinical and screening audiometers used in occupational health and ENT clinics. It competes directly with SMART TONE in the same occupational screening segment.
• Tremetrics: Tremetrics (a division of William Demant / Demant) manufactures occupational hearing testing equipment including the RA500 audiometer, which is already integrated with SmartMove Cloud. It is both a competitor and a data-source partner.
• Benson Medical Instruments: Benson Medical Instruments specializes in audiometric equipment specifically designed for occupational health and hearing conservation programs, the same target segment as Smart Diagnostic Devices.

Broad incumbents

• Demant: Demant is a global hearing healthcare conglomerate that owns multiple audiometer brands (MAICO, Interacoustics, MedRx, Tremetrics). The Demant email domain appears to handle Smart Diagnostic Devices' privacy communications, making it a relevant incumbent player in the same space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/watch?v=NL-z3HhaKHg
• Xx.com/smartmovecloud
• LinkedInlinkedin.com/company/smart-diagnostic-devices

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Smart Diagnostic Devices