(103 days)
The Otomag™ Alpha Sound Processor is intended for use with the Otomag™ Headband or Otomag™ Softband (no age limitations), or with the Otomag™ 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 10dB 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 Otomag™ Bone Conduction Hearing System is a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations. The subject of this 510(k) is to obtain a labeling claim relative to the use of MRI with the Alpha (M) Magnetic Implant to specify the implant as Magnetic Resonance (MR) Conditional.
The Otomag™ System is configured in either of two configurations. The first configuration is the Alpha (S), where the Otomag™ Sound Processor is attached magnetically to a Headband or Softband. The second configuration is Alpha (M), where the Otomag™ Sound Processor is attached magnetically to an implanted magnet. The Headband, Softband, or Magnetic İmplant holds the sound processor against the head, and vibration is transduced through direct contact with the patient's skin and the bone below.
The Otomag™ System is 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 Otomag™ System for individual patient hearing loss.
The system utilizes the same fundamental scientific principles, and has the same intended use and indications for use as the current legally marketed device, and represents that the magnetic implant can now undergo MRI scanning under certain conditions.
The provided text describes the safety and performance testing for the Otomag Bone Conduction Hearing System, specifically focusing on the Alpha (M) Magnetic Implant's MR Conditional status.
Here's an analysis based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Results |
|---|---|---|
| MRI Safety | ||
| MR Conditional Scanning Conditions | - Removal of all external components (Otomag Alpha Sound Processor, Magnetic Spacer, Headband/Softband) before entering the MR environment. |
- Static magnetic field of 3 Tesla or less.
- Spatial gradient field of 720 Gauss/cm or less.
- Maximum whole-body averaged specific absorption rate (SAR) of 4 W/kg in First Level Controlled Mode.
- Maximum scan time of 15 minutes of continuous scanning. | The non-clinical testing demonstrated that the Alpha (M) Magnetic Implant is MR Conditional and can be scanned safely under these exact specified conditions. |
| Translational Attraction | Magnetic force within the range of forces expected in normal daily usage (up to 2.5 N). | Maximum measured magnetic force was 2.29 Newtons (230 grams), which is within the range of forces expected in normal daily usage (up to 2.5 N). The implant is secured by 5 screws (holding force >150 N), mitigating hazard. |
| Torque | No hazard to the patient. | Qualitatively measured torque was "+4 (very strong)," indicating rapid and forceful alignment. However, due to the implant's small mass (3.6 grams), relatively larger translational attraction (2.5 N), and securing by 5 screws (>150 N retention force), there are no concerns that torque will cause a hazard. |
| MRI Related Heating | Maximum temperature rise less than specified thresholds during MR scanning. | Produced a maximum temperature rise less than 3.2°C during 15 minutes of continuous MR scanning (First Level Controlled Mode, 4 W/kg SAR).
Computed implant temperature increase from worst-case gradient field is less than 2.6°C. |
| Image Artifact | Characterization of artifact extent. | Image artifact extends approximately 5 cm from the device when scanned in non-clinical testing (T1-weighted, spin echo, and Gradient echo sequences in a 3 Tesla MR system). |
| Implant Function After MR Scanning (Demagnetization) | Maintains sufficient magnetic strength (e.g., >95% of original magnetic strength) after exposure to MR environment. | Maintained over 95% of its original magnetic strength after 10 insertions into a static MRI field and over 10 minutes of pulse sequence in a 3 Tesla Siemens Tri Clinical MRI Scanner. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated as a number of devices or implants tested. The text refers to "non-clinical testing" of "the Alpha (M) Magnetic Implant." For MRI compatibility testing, often a representative number of devices (e.g., 3-5) are used for each test (displacement, torque, heating, image artifact, function). It's typically not a clinical population sample size.
- Data Provenance: The studies are "non-clinical testing," meaning they were conducted in a laboratory setting. There is no mention of human or animal subjects for these specific tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable in this context. The "ground truth" here is established by standardized engineering tests and measurements against predefined physical criteria (magnetic force, temperature change, artifact size, magnetic strength retention), as outlined by ASTM standards. There is no expert consensus on clinical interpretation for these specific tests, as they are focused on device physics and safety.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation of results requiring adjudication (e.g., medical image reading). The results are quantitative measurements from physical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This submission is for establishing MR Conditional labeling, based on non-clinical engineering tests, not for evaluating human reader performance with or without the device in a clinical setting.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Yes, in a sense. The entire submission is based on the standalone performance and safety of the Alpha (M) Magnetic Implant itself, without human intervention or interpretation, in various magnetic resonance environments.
7. The Type of Ground Truth Used
The ground truth used for these tests is engineering measurement against industry standards. Specifically, the tests conform to the following ASTM standards:
- ASTM F2503-08: Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
- ASTM F2052-06e1: Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
- ASTM F2213-06 (Reapproved 2011): Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
- ASTM F2182-11a: Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging.
- ASTM F2119-07: Evaluation of MR Image Artifacts from Passive Implants.
8. The Sample Size for the Training Set
Not applicable. These are non-clinical hardware tests, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable (as above).
§ 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.