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The Otomag™ Alpha Scund 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 tose 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 100B 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 bearing in the ● opposite ear, who for some reason will not or cannot use an AC CROS. The pure tome 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 subject of this Traditional 510(k) is to obtain clearance for a modification in the method of sterifization and packaging for the Alpha (M) Magnetic Implant, cleared under 510(k) K102199, and the Surgical and Implant Templates, via a Letter to File under 510(k) K102199, and to supply these components of the system as sterile. The predicate device components are provided nonsterile and must be sterifized prior to implantation by gravity steam (autoclaving). The proposed method of sterilization for these components is by Ethylene Oxide (EO). 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 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 the Alpha (M), where the Otomag™ Sound Processor is attached magnetically to an implanted magnet. The Headband, Softband, or Magnetic Implant 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 toss 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 avoilable to the audiologist in the software allow for programming the Ottomage System for individual patient hearing loss.

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 Otomag Alpha I Sound Processor is intended for use with the Otomag Headband or Olomag Softband (no age limitations), or with the Otomag Osseointegrated 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 Otomag System consists of two distinct configurations; Alpha 1 (S) and Alpha 1 (M). This 510(k) is being submitted to add the Alpha 1 (M) configuration to the existing product family. In the Otomag Alpha 1 (S), the Otomag Sound Processor is attached magnetically to a headband or softband. The headband or softband holds the sound processor against the head and vibration is transduced through direct contact with the patient's skin and the bone below. In the Otomag Alpha 1 (M), the Otomag Sound Processor is attached magnetically to an implanted magnet assembly. The magnetic field holds the sound processor against the head and vibration is transduced through direct contact with the patient's skin and the bone below. A variety of magnetic spacers, each with a different magnetic strength, are provided with the Alpha 1(M) configuration to allow adjustment of the magnetic field strength that holds the sound processor against the head. The magnetic implant of the system is provided clean and non-pyrogenic, but is not sterile. The implant is intended to be sterilization at the healthcare facility immediately prior to implementation. 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 Otomag Alpha 1 Sound Processor is intended for use with the Otomag Headband or Otomag Softband (no age limitations) 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 Alpha 1 (S) Sound Processor is intended to the Otomag Headband or Softband.

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 Otomag System called the Alpha 1 (S), the Otomag Sound Processor is attached magnetically to a headband or softband. The headband or softband 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.