(205 days)
The Sophono® Sound Processor is intended for use with the Sophono® Headband (no age limitations), or with the Sophono® Magnetic Implant (patients 5 years of age and up) for the following patients and indications:
- Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2, and 3 kHz).
- Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 4 kHz, or less than 15 dB at individual frequencies.
- Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear, who for some reason will not or cannot use an AC CROS. The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
The Sophono® Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations.
The Sophono® (S) configurations are held directly against the head using either a soft band or a headband with the Sophono™ Sound Processor. The vibration from the Sound Processor is transduced through direct contact with the patient's skin and the bone below.
The Sophono® (M) configuration is magnetically attracted to the Sophono® Sound Processor through a Magnetic Implant, and a Magnetic Spacer. The Magnetic Implant attracts a Magnetic Spacer that is held against the head through magnetic attraction forces to the Magnetic Implant, with the Sound Processor also held magnetically against the Magnetic Spacer. The vibration from the Sound Processor is transduced through direct contact with the patient's skin and the bone below to the inner ear.
The Sophono® Systems are designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing loss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments available to the audiologist in the software allow for programming the Sophono® Systems for individual patient hearing loss.
The provided text describes the Sophono® Bone Conduction Systems (S and M Configurations) and their performance, primarily through bench testing to establish substantial equivalence to predicate devices. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or clinical outcomes for hearing improvement. Instead, the "Performance" section focuses on regulatory and engineering testing.
Therefore, I cannot populate sections regarding specific clinical performance metrics (e.g., sensitivity, specificity), sample sizes for clinical trials, expert ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided document.
Here's a summary of the information that can be extracted or inferred from the text, as well as where specific requested information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated as performance metrics in a table form) | Reported Device Performance (from "Performance" section) |
|---|---|---|
| Sterilization | Implicit: Device must be effectively sterilized and maintain sterility. | - Sterilization testing in accordance with ISO11135-1 |
- Sterilization testing in accordance with ISO 11138-1
- Sterilization testing in accordance with EN 1422 |
| Biocompatibility | Implicit: Device materials must be biocompatible. | - Biocompatibility testing in accordance with ISO 10993-1, ISO 10993-7 |
| Packaging Integrity | Implicit: Packaging must protect the device and maintain sterility. | - Packaging testing in accordance with ISO 11607-2 - ASTM F88/F88M-09. Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| Electrical Safety | Implicit: Device must meet electrical safety standards. | - Electrical testing in accordance with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Implicit: Device must operate without undue electromagnetic interference and be immune to it. | - Electromagnetic compatibility testing in accordance with IEC 60601-1-2 |
| Transportation Durability | Implicit: Device must withstand transportation stresses. | - Transportation testing in accordance to ISTA 2A |
| Software Verification & Validation | Implicit: Software must be safe and perform as intended. | - Software verification and validation in accordance with IEC 62304 |
| MRI Compatibility | Implicit: Device must be safe for use in an MRI environment. | - ASTM F2503-08, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment - ASTM F2052-06e1, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2213-06, (Reapproved 2011), Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2182-11a, Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
- ASTM F2119-07, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
| General Functional Performance | Implicit: Device must function as intended (e.g., sound transmission). | - Engineering and functional testing including system, mechanical, electrical and general functional testing |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable and not mentioned. The document describes bench testing, not a clinical test set with patient data for assessing a device's diagnostic or therapeutic performance.
- Data provenance: Not applicable. The "Performance" section describes results from engineering and regulatory compliance testing, not clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The testing described is engineering and regulatory, not clinical assessment requiring expert ground truth.
4. Adjudication method for the test set
- This information is not applicable and not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case comparative effectiveness study was not mentioned or performed, as this device is a hearing aid system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a bone conduction hearing system, not an algorithm, and its performance is assessed directly through physical and electrical testing.
7. The type of ground truth used
- The "ground truth" for the performance described relies on established engineering standards, accredited laboratory tests, and regulatory guidelines (e.g., ISO, ASTM, IEC standards). There isn't "expert consensus" or "pathology" in the traditional sense, but rather adherence to predefined technical specifications and safety parameters.
8. The sample size for the training set
- Not applicable and not mentioned. This device does not use an "AI algorithm" that requires a training set.
9. How the ground truth for the training set was established
- Not applicable and not mentioned.
§ 874.3302 Bone-conduction hearing aid.
(a)
Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II.