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).

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2016

Sophono, Inc. Ms. Rozanne Paciej Regulatory Affairs Project Manager 5744 Central Ave #100 Boulder. CO 80301

Re: K153391

Trade/Device Name: Sophono Bone Conduction Systems (S) Configuration and (M) Configuration Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: May 13, 2016 Received: May 16, 2016

Dear Ms. Paciej:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known)	K153391
Device Name	Sophono (S) & (M) Bone Conduction Hearing Systems
Indications for Use (Describe)	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).
Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (8/14)

Sohono Bone Conduction System

K153391

Page 1 of 1

PSC Publishing Services (301) 443-6740
EF

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Image /page/3/Picture/0 description: The image is a logo for Sophono, a company that provides bone conduction hearing solutions. The logo consists of an orange ear-shaped symbol on the left and the company name "Sophono" in blue on the right. Below the company name is the tagline "bone conduction hearing solutions" in a smaller, lighter font.

510(k) Summary

Date summary prepared:	12/17/2015
510(k) Submitter/Holder:	Sophono Inc.5744 Central Avenue #100Boulder, CO 80301
Contact:	Rozanne Paciej (Primary)Regulatory Affairs Project ManagerTelephone: 904-332-8233Fax: 904-296-2386Email: rozanne.paciej@medtronic.comPaul Smolenski (Alternate)Senior Regulatory Affairs ManagerTelephone: 978-698-6065Email: paul.d.smolenski@medtronic.com
Trade Name:	Sophono® Bone Conduction Systems
Systems:	Sophono® (S) Configurationand Sophono® (M) Configuration
Common Name:	Bone Conduction Hearing System
Classification Name:	Hearing Aid (21 CFR § 874.3300, Class II, LXB).

Predicate Devices:

Trade/Proprietary Name:	Otomag Bone Conduction Hearing System (Primary Predicate)
Common/Usual Name:	Bone Conduction Hearing System
Classification Name:	Hearing Aid
Class/Panel:	Class II, LXB, 21 CFR 874.3300
510(k) Submitter/Holder:	Sophono, Inc.5744 Central Ave. #100Boulder, CO 80301
510(k) #s:	K132189 (including K100193, K102199, K123962)

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Trade/Proprietary Name:	Cochlear Baha® Auditory Osseointegrated Implant System: Model BI300 Implant and Model BA300 Abutment (Secondary Predicate)
Common/Usual Name:	Bone Conduction Hearing System
Classification Name:	Hearing Aid
Class/Panel:	Class II, LXB, 21 CFR 874.3300
510(k) Submitter/Holder:	Cochlear Americas13059 E. Peakview Ave.Centennial, CO 80111
510(k) #:	K100360

Device Description

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.

Indications for Use

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).

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. 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).

Technological Characteristics

The Sophono® Bone Conduction Hearing Systems transmits audio vibrations through the skin into the bone where sound is sensed by the inner ear / cochlea.

In the Sophono® (S) configuration the Sound Processor is held against the head using a soft band or headband.

In the Sophono (M) configurations the Magnetic Implant is magnetically attracted to the Sophono Sound Processor through a Magnetic Spacer. The Magnetic Implant attracts a Magnetic Spacer that is held against the head through magnetic forces to the Magnetic Implant, with the Sound Processor magnetically attracted to the Magnetic Spacer. The vibration from the Sound Processor is transduced through direct contact with the patient's skin and the bone below.

The intended use, indications for use, function, and general fundamental technological operating principles of the devices have not changed.

Transcutaneous Energy Transfer (TETIN) enables sound (vibration, energy) transfer from the Sophono® Sound Processor, through the patient's skin and magnetic bone implant, to the working cochlea.

Performance

Evidence of safety and effectiveness were obtained from bench testing, which included:

Sterilization testing in accordance with ISO11135-1 .
Sterilization testing in accordance with ISO 11138-1
Sterilization testing in accordance with EN 1422 ●
Biocompatibility testing in accordance with ISO 10993-1, ISO 10993-7 ●
Packaging testing in accordance with ISO 11607-2 ●
Electrical testing in accordance with IEC 60601-1
Electromagnetic compatibility testing in accordance with IEC 60601-1-2
Transportation testing in accordance to ISTA 2A
Software verification and validation in accordance with IEC 62304 ●
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

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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
Engineering and functional testing including system, mechanical, electrical and general functional . testing

Conclusion

The results of the testing demonstrate that the proposed Sophono® Bone Conduction Hearing Systems subject devices operated as intended and are substantially equivalent to the primary predicate subject device, Otomag Bone Conduction Hearing System.

Regulation Number and Section

§ 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.