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The Ponto Bone Anchored Hearing System (Ponto sound processors and implant system) is intended for the following patients and indications: · Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto 4 sound processors, 55 dB HL for use with the Ponto 3 Power sound processors and 65 dB HL for use with the Ponto 3 SuperPower sound processor. · 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 (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). · Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. The placement of a bone anchored implant is contraindicated for patient below the age of 5. The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/ abutment system (refer to the Ponto labeling for compatible BAHA sound processor models).

The Ponto Bone Anchored Hearing System consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor can be connected and disconnected by the user by the snap coupling. The technological characteristics of the Ponto Bone Anchored Hearing System, Ponto Implant System, remain unchanged from the original design (most recently cleared in K152067). The Ponto Bone Anchored Hearing System also include accessories and instruments for installation of the implantable components, and the Ponto Surgical Manual and Surgical Manual Addenda include step by step instructions for a number of safe alternative surgical approaches for implant installation. The main purpose of this 510(k) notification is a modification to the drilling to prepare the osteotomy for installation of a Ponto bone anchored implant, from two-step drilling (MIPS previously cleared in K152067) to a single drill step (MONO). The MONO Surgery Kit is a further development of the MIPS Surgery Kit previously cleared in K152067.

The Cochlear Baha Connect System (Baha sound processors and implant/abutment system) is intended for the following patients and indications for use: - Patients aged 5 and older - Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the Baha 4 and Baha 5 sound processors, 55 db HL for use with the Baha 5 Power sound processors, and 65 db HL for use with the Baha 5 SuperPower Sound Processors. - Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conductive thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15dB difference at individual frequencies. - Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deafness: SSD™). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL. - Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. Specific models of the Cochlear Baha abutments can be used with either the Cochlear Baha Connect System or compatible sound processors from Oticon Medical AB. Refer to the Cochlear Baha abutment labeling for a list of compatible Oticon Medical sound processors.

A bone anchored hearing system consists of a sound processor connected to an implant with a skin penetrating abutment. The implant is surgically anchored in the skull bone behind the ear. Vibrations generated by the sound processor are transmitted via the implant directly through the skull bone to the cochlea as bone conduction sound. The BA310 abutments are modifications of the previously cleared BA300 abutments and provide additional sound processor compatibility than the previously cleared abutments. Compared to the currently cleared BA300 and BA400 Abutments, a small "flange" has been added to the upper part of the BA310 Abutment and the core diameter of the abutment has been reduced by 0.7mm. This design allows sound processors from Oticon Medical to snap on the outside of the abutment while maintaining the same snap in coupling design for connection to Baha sound processors.

The Ponto bone anchored hearing system (Ponto sound processors and implant system) is intended for the following patients and indications: - . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto, Ponto Pro and Ponto Plus sound processors, 55 dB HL for use with Ponto Pro Power and Ponto Plus Power sound processors. - . 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 (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). - o Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. The placement of a bone anchored implant is contraindicated for patients below the age of 5. The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto bone anchored hearing system consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. The technological characteristics of the Ponto bone anchored hearing system remain unchanged. The Abutment extension accessory added to the Ponto bone anchored hearing system is a noninvasive component to be mounted on the abutment as point of attachment for the Ponto sound processor. The Abutment extension can be used with Ponto abutments and selected abutments from Cochlear BAS. When attached to the abutment it allows for connection of Ponto sound processors.

The Ponto bone anchored hearing system intended use is for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single-sided deafness. The Ponto bone anchored hearing system (Ponto sound processors and implant system) is intended for the following patients and indications: - . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto, Ponto Pro and Ponto Plus sound processors, 55 dB HL for use with Ponto Pro Power and Ponto Plus Power sound processors. - . 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 (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). - . Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. The placement of a bone anchored implant is contraindicated for patient below the age of 5. The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implant from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto bone anchored hearing system consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. The technological characteristics of the Ponto bone anchored hearing system remain substantially unchanged from the original design. A modification has been made to the 4.5 mm diameter implant, introducing Ponto BHX implants with a rougher surface topography on parts of the implant. The purpose of the modification is to enhance osseointegration properties of the implant. In addition, minor modifications have been made to surgical instruments for a less invasive surgical approach, Minimally Invasive Ponto Surgery (MIPS), for installation of Ponto implants. Instead of a linear incision, a single circular incision is created by means of a biopsy punch equivalent in size to the implant/abutment, enabling access for placement of the implant in the bone.

The Ponto bone anchored hearing system (Ponto sound processors and implant system) is intended for the following patients and indications: - . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto, Ponto Pro and Ponto Plus sound processors, 55 dB HL for use with Ponto Pro Power and Ponto Plus Power sound processors. - 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 (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). - Also indicated for any patient who is indicated for an air-conduction contralateral ● routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. The placement of a bone anchored implant is contraindicated for patient below the age of 5. The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto bone anchored hearing system consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant is placed in or around the mastoid region of the skull on either one or both sides. The implant is then used as anchorage for the skin penetrating abutment that connects to the external sound processor. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor has a coupling so that it can easily be connected to and disconnected from the abutment by the user. This submission concerns the abutment component.

The Cochlear Baha® auditory osseointegrated implant system using model BA400 abutment is intended for the following patients and indications for use: - Patients aged 5 and older - Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the BP100 sound processor, 55 dB HL for use with the Intenso sound processor, 55 db HL for use with the BP110 Power sound processor, and 65 db HL for use with the Cordelle II Sound Processor. - Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conductive thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15dB difference at individual frequencies. - Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deafness: SSD™). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 ав нг - Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The Baha implant system functions by combining 3 parts: a titanium implant, a percutaneous abutment, and a sound processor. The system works by utilizing natural bone transmission as a pathway for sound to travel to the inner ear, bypassing the external auditory canal and middle ear. After surgical placement, the titanium implant naturally integrates with the skull bone over time through a process known as osseointegration. The external sound processor transmits sound vibrations through the percutaneous abutment to the titanium implant. The vibrating implant creates vibrations within the skull that stimulate the nerve fibers of the inner ear, allowing hearing. The minor changes to this device are only to the abutment, the piece that serves as the connection between the osseointegrated implant and the external sound processor. The changes include a modified design and the addition of a hydroxyapatite coating, neither of which modify the intended functionality or fundamental operating principles of the implant/abutment system.

The Ponto bone anchored hearing system is intended for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness. The Ponto bone anchored hearing system (sound processors Ponto, Ponto Pro and Ponto Pro Power and implant system) is intended for the following patients and indications: - Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto and Ponto Pro sound processors, 55 dB HL for use with the Ponto Pro Power sound processor. - 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 (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). - Also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. The placement of a bone anchored implant is contraindicated for patient below the age of 5. The Ponto sound processors are intended to be used with the Ponto implant system (all models) or the Baha abutment snap coupling from Cochlear Bone Anchored Solutions (BAS) according to the below; The Ponto implant system can be used for connection of the Ponto sound processors (all models) or the Baha sound processors with snap coupling from Cochlear BAS according to the below;

The Ponto bone anchored hearing system consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user.

The Ponto bone anchored hearing implant system is intended for the following patients and indications; - . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto and Ponto Pro sound processors, 55 dB HL for use with the Ponto Pro Power sound processor. - . 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 (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). - Also indicated for any patient who is indicated for an air-conduction contralateral routing of . signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

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The Baha Cordelle II sound processor is intended for use with the Baha auditory osseointegrated implant for the following patients and indications; - . Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 65 dB HL. - Bilateral fitting of the Cordelle II is intended for patients who meet the above e criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies. - Patients who suffer from unilateral sensorineural deafness in one ear with normal # hearing in the other ear (i.e. single-sided deafness or "SSD"). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL. - . Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The Baha system works by combining a sound processor with an abutment and a small titanium implant placed in the skull behind the ear. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the bone, allowing high-quality amplified and processed sound to be conducted via the skull bone directly to a cochlea with residual functionality. The Cordelle II is one of three currently marketed sound processors for use with the Baha auditory osseointegrated implant. It is the only analog signal processing and body-worn sound processor, and it offers the highest power output of all the devices.