(171 days)
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Yes
The document explicitly states that the Sonu Cloud Engine uses an "Artificial Intelligence / Machine Learning algorithm".
Yes
The device is indicated for the relief of moderate to severe nasal congestion and significantly reduced nasal congestion in performance studies, which are therapeutic effects.
No
The device is indicated for the relief of nasal congestion and is described as a treatment, not for diagnosing conditions.
No
The device description explicitly states that Sonu consists of an adjustable headband (Sonu Band) with integrated acoustic bone-conduction transducers and a USBC Charging Cable, in addition to the smartphone application. These are hardware components.
Based on the provided information, Sonu is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Sonu's Intended Use: Sonu is indicated for the relief of nasal congestion. It is a treatment device, not a diagnostic device.
- Sonu's Mechanism: Sonu uses acoustic bone-conduction to deliver therapy based on estimated resonant frequencies. It does not analyze biological specimens.
- Lack of Specimen Analysis: The description clearly states that Sonu uses a 3D face scan and an AI/ML algorithm to estimate frequencies. This is based on external measurements and calculations, not the analysis of bodily fluids or tissues.
While Sonu uses technology like image processing and AI/ML, these are used to personalize the treatment delivery, not to diagnose a condition by analyzing biological samples.
No
The provided input does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Sonu is indicated as follows:
Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 22 and older.
Product codes
QZC
Device Description
Sonu is a non-invasive, over-the-counter (OTC) device designed for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis at home. Sonu consists of an adjustable headband (Sonu Band) with integrated acoustic bone-conduction transducers, a USBC Charging Cable, and a smartphone application (Sonu iOS App) that connects to the Sonu Band.
Mentions image processing
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Mentions AI, DNN, or ML
The Sonu Cloud Engine estimates patient-specific resonant frequencies. of nasal cavities and sinuses (using an Artificial Intelligence / Machine Learning algorithm that has been trained to correlate craniofacial measurements with sinus dimensions) and sends the Sonu App instructions to sequence and play them (deliver treatment), as an audio file, via the Sonu Band.
Input Imaging Modality
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Anatomical Site
Sinus and nasal areas / Forehead
Indicated Patient Age Range
22 and older
Intended User / Care Setting
Individuals at home
Description of the training set, sample size, data source, and annotation protocol
The Sonu Cloud Engine estimates patient-specific resonant frequencies. of nasal cavities and sinuses (using an Artificial Intelligence / Machine Learning algorithm that has been trained to correlate craniofacial measurements with sinus dimensions) and sends the Sonu App instructions to sequence and play them (deliver treatment), as an audio file, via the Sonu Band.
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The SCORE (Sonu nasal COngestion RElief) Study was a multi-center, randomized, double blinded, sham-controlled (Sonu versus Sham, randomized 1:1), interventional study of 52 subjects. The study was designed to assess the safety and effectiveness of acoustic resonance therapy as delivered through the Sonu Band in subjects suffering from moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Three (3) sites participated in the study.
Primary Safety Endpoint: Serious Adverse Events (SAEs)
Primary Effectiveness Endpoint: statistically significant improvement in nasal congestion sub-score of TNSS, comparing baseline congestion at screening versus daily congestion averaged over 2 weeks (Sonu vs. Sham).
Secondary Safety Endpoint: Adverse Events (AEs)
Secondary Effectiveness Endpoint: statistically significant improvement in 24-hour reflective TNSS comparing baseline TNSS at screening versus daily TNSS averaged over 2 weeks (Sonu vs. Sham).
Results:
The SCORE study enrolled and randomized 52 subjects (26 Sonu Therapy and 26 Sham).
Primary Safety: The primary safety endpoint was achieved based on the absence of any reported Serious Adverse Events (Table 3). Furthermore, there were no reports of any adverse events or complications related to the device or treatment.
Primary Effectiveness Analysis - Nasal Congestion Sub-score: The primary effectiveness endpoint was achieved, based on the statistically significant reduction in the nasal congestion sub-score in the Sonu Therapy arm compared to Sham. At 2-week followup, the mean change in nasal congestion sub-score was -0.87 in the Sonu Therapy group and -0.44 in the Sham group (p=0.008).
Secondary Safety: The secondary safety endpoint was achieved based on the absence of any reported Adverse Events (Table 4).
Secondary Effectiveness Analysis - Total Nasal Symptom Score (TNSS): For composite TNSS, the mean change at 2-week follow-up was -2.85 for the Sonu Therapy group and -1.32 for the sham group (p=0.027).
Key Metrics
Primary Endpoint - Nasal Congestion Sub-score:
Sonu Therapy Mean change: -0.87 (95% CI: -1.11, -0.62)
Sham Mean change: -0.44 (95% CI: -0.64, -0.23)
p-value: 0.008
Secondary Endpoint - Composite TNSS:
Sonu Therapy Mean change: -2.85 (95% CI: -3.85, -1.85)
Sham Mean change: -1.32 (95% CI: -2.27, -0.36)
p-value: 0.027
Safety: No Serious Adverse Events or Adverse Events reported in either group (0/52 subjects).
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
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DE NOVO CLASSIFICATION REQUEST FOR
SONU
REGULATORY INFORMATION
FDA identifies this generic type of device as:
External mechanical stimulator for the relief of congestion. An external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.
NEW REGULATION NUMBER: 21 CFR 874.6010
CLASSIFICATION: Class II
PRODUCT CODE: QZC
BACKGROUND
DEVICE NAME: Sonu
SUBMISSION NUMBER: DEN230045
DATE DE NOVO RECEIVED: June 16, 2023
SPONSOR INFORMATION:
Sound Health Systems, Inc. % Sloan Regulatory Consulting, LLC 322 Hart Rd. Gaithersburg, Maryland 20878
INDICATIONS FOR USE
The Sonu is indicated as follows:
Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 22 and older.
LIMITATIONS
Limitations on device use are included in the Instructions for Use as Contraindications, Warnings, and Precautions.
Contraindications
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You should not use this device if:
- · You have a dental infection.
- · You are receiving treatment for neurological conditions.
- · You have electrostimulation devices implanted in your head, including a deep brain
stimulation (DBS) devices or cochlear implants
- · You had any type of surgery to the face, head, nose or sinuses within the past 3 months
- · You had an intracranial or and intracerebral bleeding in the past 6 months.
- · You have open wounds, rashes, over swollen, red, infected or inflamed areas,
skin eruptions or fragile skin on the forehead (treatment location).
- · You have a history of cranial surgery.
- · You are sensitive to sound.
Precautions
- · Congestion relief for greater than 2 weeks has not been studied.
· Do not attempt to perform any treatment before carefully reading this User Manual and Quick Start Manual provided with the package.
· Do not use the device on the heart, chest, neck, or any other body location other than the forehead as directed.
· Do not share the device with other people. The device is intended to be used by a single person to receive therapy based on their craniofacial anatomy.
· Refer to Sound Health Systems' website: https://soundhealth.life for detailed information.
Warnings
Sonu transmits acoustic vibrations from the bone conduction transducers in the Band to the sinus cavities. After you pair the Band with your smartphone and play the audio track, you will hear sound during treatment (essential performance).
· Do not use Sonu if you are unable to pair the Band with the Sonu App on your smartphone or do not hear sound when you play the audio track (i.e., essential performance is lost or degraded) due to electromagnetic disturbances.
· Do not use Sonu if it shuts down or the performance has degraded in any way
· Do not use Sonu near active high-frequency (HF) surgical equipment or in the radiofrequency (RF) shielded room of a magnetic resonance imaging (MRI) scanner or near RF emitting equipment where electromagnetic disturbances are high, because it could result in improper operation.
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· Avoid using Sonu adjacent to or stacked with other equipment because it could result in improper operation. If such use is necessary, please verify that Sonu and the other equipment are operating normally.
· Use of accessories, transducers and cables other than those specified or provided by the manufacturer of Sonu could result in increased electromagnetic emissions or decreased electromagnetic immunity of Sonu and result in improper operation.
· Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of Sonu, including cables specified by the manufacturer. Otherwise, degradation in performance of Sonu could result.
DEVICE DESCRIPTION
Image /page/2/Picture/4 description: The image shows three separate pictures. The first picture is a cartoon of a woman wearing a black headband. The second picture shows a hand pressing a button on a gray headband with a green light. The third picture shows a screen with the words "15:00 Remaining" and a button that says "Begin".
Sonu is a non-invasive, over-the-counter (OTC) device designed for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis at home. Sonu consists of an adjustable headband (Sonu Band) with integrated acoustic bone-conduction transducers, a USBC Charging Cable, and a smartphone application (Sonu iOS App) that connects to the Sonu Band.
Image /page/2/Figure/6 description: The image shows a diagram of a system involving a smartphone, face scanning, cloud engine, and a user. The smartphone (1) is connected to a face scanning process (2), which then sends data to a cloud engine (3). The cloud engine sends data back to the smartphone. The smartphone is also connected to a user (4) via audio and Bluetooth.
Figure 1. Sonu Components and Modes of Interaction
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The following describes each of the numbered components and interactions shown in Figure 1:
- Sonu iOS App: The user downloads the Sonu App on their iOS-based smartphone and is guided through a simple setup process involves Bluetooth pairing of the Sonu Band to the smartphone and follows the standard secure procedure to pair a headphone device via Bluetooth.
Image /page/3/Figure/2 description: The image shows instructions for charging and pairing a device. The first panel shows how to charge the band by locating the port and charging until the orange LED turns off. The second panel shows how to pair the device by launching the SONU app on your phone and following the directions, and turning the band on by finding the button through the band fabric. The third panel shows that a flashing green LED indicates the band is in pairing mode.
- 3D Face Scan: The Sonu App directs the user to perform a detailed 3D face scan using the front-facing smartphone camera and calculates vector distances for selected craniofacial landmarks based on the 3D sean. These vector values are then encrypted and sent to the Sonu Cloud Engine over wireless air interface. Note: No photos or user facial scans are stored on the smartphone or sent to the Sonu Cloud Engine to ensure compliance with user privacy.
Image /page/3/Picture/4 description: The image shows a face scan being performed on a person. A phone is scanning the face of a person with a grid-like pattern. On the right side of the image, a face scan is complete with a check mark. The text says, "Face scan complete!"
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- Sonu Cloud Engine: The Sonu Cloud Engine estimates patient-specific resonant frequencies. of nasal cavities and sinuses (using an Artificial Intelligence / Machine Learning algorithm that has been trained to correlate craniofacial measurements with sinus dimensions) and sends the Sonu App instructions to sequence and play them (deliver treatment), as an audio file, via the Sonu Band.
Image /page/4/Figure/1 description: The image contains two figures. The figure on the left is a 3D rendering of a face made up of green dots. The figure on the right is a diagram of a face with labels pointing to different parts of the face, including the vibratory actuator, frontal sinus, ethmoid sinuses, maxillary sinus, and headband.
- Treatment Delivery via Bluetooth-paired Sonu Band: The Sonu App then synthesizes, sequences, and plays the audio file through the Sonu Band's acoustic bone conduction transducers to deliver patient-specific treatment. Each dose consists of a 15-minute playback sequence. The recommended treatment is two doses per day for relief of congestion.
Image /page/4/Figure/3 description: The image shows a diagram of the Sonu system. The system consists of a user with a Sonu headband, a Sonu app, and a cloud engine. The user's headband connects to the Sonu app via Bluetooth, and the Sonu app connects to the cloud engine via HTTPS/AES and an air interface (5G/Wifi).
The acoustic energy levels of the Sonu Band are below that specified by the World Health Organization (WHO) for safe headphone operation for the maximum dosage period (