Atch.2_Salient Characteristics FA282325Q0080.pdf
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- Solicitation number
- FA282325Q0080
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This document presents Salient Characteristics for a Recorder, Physiologic, Evoked Potential, Auditory, dated 28 Aug. 2025, with solicitation number FA2823-25-Q-0080. The Auditory Diagnostic System is an advanced, prescription-grade medical device designed for professional hearing assessments across all age groups, supporting comprehensive auditory testing. It offers six key auditory assessments including ABR, ECochG, ASSR, 40 Hz ERP, TEOAE, and DPOAE, with a wireless, portable design that enables testing in diverse clinical environments like NICUs and operating rooms.
The system features superior noise handling through adaptive processing, wireless data transmission up to 30 feet, and advanced patient safety capabilities like non-sedated testing. Technical specifications include a Windows 10/11 laptop, single/dual-channel audiometer, insert earphones, bone conductor, and OAE probes. Key technical capabilities include wide stimulus ranges (clicks up to 99 dB nHL, tonebursts up to 105 dB nHL), adjustable recording filters, and the ability to measure multiple physiological metrics like latencies, amplitude ratios, and interpeak intervals. The device eliminates the need for shielded test rooms and provides in-situation amplification to reduce electromagnetic interference and muscle artifacts.
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| File | Type | Posted |
|---|---|---|
| Atch.1_Provisions & Clauses FA282325Q0080.pdf | ||
| Atch.3_Requirements List FA282325Q0080.pdf |
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SALIENT CHARACTERISTICS
Recorder, Physiologic, Evoked Potential, Auditory
Atch. 2_FA2823-25-Q-0080 28 Aug. 2025
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1. Overview & Clinical Purpose
• The Auditory Diagnostic System is an advanced, prescription-grade auditory diagnostic system designed for trained professionals to aid in detecting hearing loss, auditory pathway lesions and vestibular pathway.
• It’s suitable for testing across the lifespan—from newborns to adults—and supports a comprehensive test battery.
2. Core Test Modalities
Supports six key auditory assessments:
• ABR (Auditory Brainstem Response) Sedated and Non-sedated
• ECochG (Electrocochleography) Non-invasive
• ASSR (Auditory Steady-State Response) Fully Automated
• 40 Hz ERP (Event-Related Potential)
• TEOAE (Transient Evoked Otoacoustic Emissions)
• DPOAE (Distortion Product Otoacoustic Emissions)
• High Frequency ABR
• Cortical MLR/LLR (Cortical Middle Latency Response/Late Latency Response
• VEMP (Vestibular Evoked Myogenic Potential)*
3. Wireless, Portable Design
• Utilizes wireless interface, transmitting data up to 30 ft to the clinician’s computer, enhancing mobility and adaptability—even outside shielded environments.
• Enables testing in locations like NICUs, operating rooms, or during tele audiology sessions where traditional cabling is impractical.
4. Superior Noise Handling & Artifact Reduction
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• Adaptive Processing with Kalman-weighted averaging that does not reject noisy sweeps, improving efficiency and reliability.
• Provides in-situation amplification to reduce electromagnetic interference and muscle artifacts, even in noisy clinical environments like NICUs or ORs.
• Eliminates the need for shielded test rooms—significantly minimizes noise interference and environmental artifacts.
5. Patient Safety & Comfort
• Enables non-sedated ABR testing, reducing sedation risks by up to 66%, minimizing delays, caregiver anxiety, and improving throughput.
• Infants and children can be tested in natural settings—held, swaddled, in strollers— thanks to wireless connectivity.
6. Technical & Regulatory Specs
• Hardware components include:
o Portable Windows 10/11 laptop with required software preinstalled o Single-channel or dual-channel audiometer o Insert earphones, bone conductor, and OAE probes.
o ECochG electrode ear tip cable o Probe cleaning tools o Two sets of rechargeable batteries
• Software components include:
o Required operating software for clinician to read results of tests on vendor provided computer.
• Stimuli and recording specs:
o Wide intensity & frequency ranges for ABR: clicks up to 99 dB nHL, tonebursts up to 105 dB nHL, chirps up to 111 dB nHL.
o Recording window: 0–120 ms; filters adjustable (high-pass 30–300 Hz, low-pass
300–3000 Hz).
o Measures latencies, amplitude ratios, interpeak intervals, and correlation coefficients. ASSR supports simultaneous multi-frequency testing with automated threshold estimation.
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Summary Overview Table
Category Key Feature Highlights
Test Modalities ABR, ECochG, ASSR, 40 Hz ERP, TEOAE, DPOAE
Mobility & Comfort Wireless, portable, sedated and non-sedated testing
Noise/Interference Adaptive Processing with Kalman-weighted averaging that does not reject noisy sweeps, improving efficiency and reliability.
Software Advanced visualization, usability, and clinical tools
Technical Specs Wide stimulus ranges, adjustable filters, multi-output metrics
File details come from the government source that posted it. Updated .