AcuPebble SA100 Home Sleep Test
Strong Clinical Evidence
FDA 510(k) Cleared
Home Sleep Tests

AcuPebble SA100 Home Sleep Test

by Acurable Model: AcuPebble SA100

92/100
Clinical Score
HSA/FSA: Usually Eligible

Key Features

Acoustic Biomarkers: Proprietary technology detects respiratory and cardiac disease markers through physiological body sounds.
High Usability: Clinical trials show 100% of patients successfully complete the test without training.
Minimal Disruption: Lightweight 7g sensor eliminates the need for nasal cannulas, wrist straps, or abdominal belts.
Instant Reporting: Automated algorithms generate detailed diagnostic reports within minutes of data upload.

Device Overview

The AcuPebble SA100 is a miniature, non-invasive wearable device that attaches to the base of the neck to record physiological body sounds. It uses patented acoustic signal processing to automatically extract diagnostic parameters for sleep apnea, such as AHI and ODI, without requiring training or restrictive chest belts.

Technical Specifications

Model Number AcuPebble SA100
Manufacturer Acurable
Connectivity
Bluetooth
Category Home Sleep Tests
Channels Monitored (airflow/effort/SpO2/position) Acoustic signals (Respiratory pattern/cardiac features), Body Position, and Activity.
AHI Detection Range Validated for moderate-to-severe OSA detection (95.3% accuracy).
Recording Duration (nights) Multi-night capable; rechargeable sensor allows for consecutive sleep sessions.
Sensor Types Neck-worn acoustic sensor with integrated 3-axis accelerometer.
Data Format & Export Bluetooth transfer to mobile app; automated cloud-based scoring with PDF reports via a clinician portal.
FDA Classification Class II, 21 CFR 868.2375 (Breathing Frequency Monitor/Ventilatory Effort Recorder).
Board-Certified Interpretation Included Results are intended for healthcare professional review via a secure web application.
Prescription Requirement Yes, currently supplied exclusively via healthcare professionals.

Cost & Coverage Analysis

Pricing Breakdown

Medical Adhesive Tape (Single-use double-coated medical tape)
Free

HSA / FSA Eligibility

Usually Eligible

Eligibility may vary by provider and plan. Check with your HSA/FSA administrator for specific details.

Clinical Review

Evidence-based evaluation by medical professionals

"A revolutionary wearable that replaces complex belts and cannulas with a single acoustic sensor for high-accuracy, automated OSA diagnosis."
Strong Clinical Evidence Recommended
92
Score

The AcuPebble SA100, developed by Acurable, introduces a novel approach to home sleep apnea testing by utilizing acoustic sensing technology. Instead of traditional channels like nasal airflow or finger pulse oximetry, the device is a single 7-gram sensor attached to the suprasternal notch of the neck with medical adhesive. It records the physiological sounds generated by respiratory and cardiac functions, which are then processed by patented algorithms to derive key diagnostic parameters including the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI). A landmark study published in BMJ Open demonstrated that the AcuPebble SA100 achieved a 95.33% diagnostic accuracy when compared against gold-standard polygraphy. The system is entirely automated; patients follow instructions via a mobile app, upload their data to the cloud, and a clinically validated report is generated instantly for the healthcare provider.

Comparative Performance

Ranked #5 of 25 clinically evaluated home sleep tests devices

1
Withings Sleep Analyzer

Withings Sleep Analyzer

Withings

Top Rated
2
Sunrise Home Sleep Test

Sunrise Home Sleep Test

Sunrise SA

3
NightOwl Home Sleep Apnea Test

NightOwl Home Sleep Apnea Test

ResMed

5
AcuPebble SA100 Home Sleep Test

AcuPebble SA100 Home Sleep Test

Acurable

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92 /100

Clinical Context

Our #1-ranked home sleep tests device demonstrated superior performance across key clinical metrics. Compare detailed specifications to make an evidence-based selection.

Where to Buy

Verified retailers and current pricing

Acurable (HCP Inquiry)

Varies by healthcare provider

Prescription required; primarily B2B supply to clinics and hospitals.

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Hunrosa Sleep Specialist (UK)

Price: $465.00
3-5 business days

Price includes diagnostic test, clinical report, and specialist consultation (GBP 370).

Shop Now

Important Information

  • • Prices and availability subject to change
  • • Some devices may require a prescription
  • • HSA / FSA eligibility: Usually Eligible
  • • Purchase from authorized retailers for warranty protection
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