Advanced Diagnostic & Vestibular Product Engineering

We provide comprehensive hardware and software design and development for a complete portfolio of diagnostic audiology products, focusing on accuracy, efficiency, and user experience. All software development adheres to IEC 62304 Medical Software Lifecycle standards, ensuring safety, reliability, and regulatory readiness from the ground up.

• Core Audiometry Suites: Modules engineered for clinical precision and streamlined workflows.
  - Pure Tone Audiometry
  - Tympanometry
  - Speech Audiometry
• Specialized Segments:
  - Neo-Natal Screening: Rapid, reliable Automated Auditory Brainstem Response (AABR) and Otoacoustic Emissions (OAE) systems to meet universal screening mandates.
  - Verification & Fitting: Integrated Real-Ear Measurement (REM) capabilities to ensure optimal prescriptive fitting accuracy.
  - Balance Assessment: Electronystagmography (ENG) and Videonystagmography (VNG) platforms for comprehensive vestibular function testing.
  - Enhanced Functionality: Development of sophisticated, proprietary features like Ambient Noise Detection, advanced Feedback Management, and Tinnitus Management solutions to differentiate your product line.

Verification & Validation (V&V) 

Ensure rapid market entry and global compliance with our expert V&V services, guaranteeing that all devices meet the highest international performance and safety standards.

• Full-scope Design & Development and Verification & Validation adherence to critical regulatory specifications such as: ANSI S3.6, IEC 60645 Series, ISO 8253-1 & 8253-3
  - Device & Measurement V&V: Comprehensive validation for diagnostic hearing and balance devices, measurements, and target verification protocols.
  - Hearing-Aid Target Verification: Rigorous V&V against industry-standard prescriptive fitting formulae: NAL-NL2, NAL-NL3, and DSL v5.0 to ensure clinical efficacy and provider confidence.
• Interoperability & Data Integrity:
  - Industry Protocol Compliance: Dedicated expertise in IMC Protocols, HIMSA Documentation, and ensuring full NOAH Conformance for seamless integration into clinical workflows.
  - V&V of Custom Fitting Products and Proprietary Algorithms.

Next-Generation AI & Low-Latency Hearing Solutions

Future-proof your hearing instrument portfolio with cutting-edge, processor-optimized algorithms.

• State of the Art: Design and development of next-generation, low-latency, AI-enabled hearing-aids.
• Real-Time Optimization: Optimization of digital signal processing (DSP) using AI-based algorithms for real-time sound enhancement, intelligent content-type classification (e.g., speech-in-noise, music, silence).

Seamless Software & Data Ecosystem Integration

We develop the core software infrastructure to enhance clinical workflow efficiency and data security.

• Integrated Patient Management Software (PMS): Development and seamless integration of your proprietary audiology software with clinic-wide Patient Management Systems (PMS), fully conforming to NOAH standards for unified data management.
• Custom Reporting & Documentation: Creation and customization of detailed, compliant Diagnostic Reports through an integrated, flexible report management system, providing audiology professionals with actionable, clean data.

Key challenges Audiology OEMs face:

• Complex product lifecycles that demand seamless hardware, software, and AI integration.
• Heavy regulatory compliance burdens (IEC, ANSI, ISO, IEC 62304) that extend release timelines.
• Interoperability challenges with PMS, NOAH, and EMR/EHR systems.
• Need for precision and advanced features (neonatal screening, balance tests, AI-driven diagnostics) while keeping costs in check.
• Outdated legacy platforms that slow innovation and increase maintenance overhead.
• Data privacy and security concerns (HIPAA, GDPR) adding to compliance complexity.
• User adoption barriers from clunky UX and workflows in clinical environments.

What we help you build:

• AI-powered audiometry platforms
• HL7-integrated Patient Management Systems
• Regulatory-ready software solutions
• Embedded systems and firmware for audiology hardware
• Modernized, scalable software architectures
• HIPAA-compliant cloud solutions
• User-centric audiology interfaces