Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm

K142678 · Oticon Medical AB · MAH · Jan 21, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K142678
• Device Name: Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm
• Applicant: Oticon Medical AB
• Product Code: MAH · Ear, Nose, Throat
• Decision Date: Jan 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3302
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

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).

Device Story

Bone anchored hearing system; consists of external sound processor, titanium implant, and skin-penetrating abutment. Implant placed in mastoid region; abutment provides mechanical coupling for sound processor. Processor converts sound to vibrations; transmitted through skull bone directly to cochlea via bone conduction. User-operated; processor easily connected/disconnected from abutment. Modification adds 14mm abutment to existing 6mm, 9mm, 12mm range. Benefits patients with conductive/mixed hearing loss or single-sided deafness by bypassing damaged outer/middle ear structures.

Clinical Evidence

Bench testing only. Mechanical force testing performed to verify performance of the 14mm abutment compared to previously cleared abutments.

Technological Characteristics

System comprises external sound processor, implant, and skin-penetrating abutment. Principle: bone conduction via skull vibration. Modification: expansion of abutment length range to include 14mm. No changes to materials or fundamental design compared to predicates.

Indications for Use

Indicated for patients age 5+ with conductive/mixed hearing loss (PTA BC threshold ≤45-55 dB HL depending on processor) or single-sided deafness (profound sensorineural loss in one ear, normal hearing in other, AC threshold ≤20 dB HL). Also indicated for patients requiring AC CROS who cannot use standard AC CROS devices. Contraindicated for patients under age 5.

Regulatory Classification

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.

Predicate Devices

• Ponto bone anchored hearing system (K112053)
• Ponto bone anchored hearing system (K121228)
• Ponto bone anchored hearing system (K132775)

Submission Summary (Full Text)

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines representing movement or connection.

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

January 21, 2015

Oticon Medical Ab c/o Ms. Carolina Wessling Quality Assurance and Regulatory Affairs Manager Ekonomivagen 2 SE-436 33 Askim. Sweden

Re: K142678

> Trade/Device Name: Ponto Bone Anchored Hearing System/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide Implant, 4mm, With Abutment, 14 Mm Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: MAH Dated: December 18, 2014 Received: December 22, 2014

Dear Ms. Wessling,

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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] 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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## Indications for Use Statement

K142678 510(k) Number (if known):_

Device Name: Ponto Bone Anchored Hearing System

Indications for Use:

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).

| Prescription Use _X_ | AND/OR | Over-The-Counter Use _ |
|-------------------------------|--------|-------------------------------|
| (Per 21 C.F.R. 801 Subpart D) | | (Per 21 C.F.R. 807 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

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# 510(k) SUMMARY

# Oticon Medical AB's Ponto bone anchored hearing system

# Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

| Submitter: | Oticon Medical AB<br>Ekonomiv. 2<br>SE-436 33 Askim<br>Sweden<br><br>Phone: [phone]<br>Facsimile: [phone] |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Carolina Anker Wessling<br>Phone: [phone] |
| Date Prepared: | September 17, 2014 |

| Name of Device: | Ponto bone anchored hearing system |
|----------------------------|-----------------------------------------|
| Common or Usual Name: | Hearing Aid, Bone Conduction |
| Classification Name: | Hearing Aid, Bone Conduction, Implanted |
| Classification regulation: | 21 CFR 874.3300 |
| Product code: | MAH |

### Predicate Devices

| Manufacturer name | Device trade name |
|-------------------|----------------------------------------------------------------|
| Oticon Medical AB | Ponto bone anchored hearing system (K112053, K121228, K132775) |

### Purpose of the 510(k) notice

The modification covered by this 510(k) is to add a longer abutment to the abutment range within the Ponto bone anchored hearing system.

### Intended Use

The Ponto bone anchored hearing system intended use is for improvement of hearing for patients 5 years or older with conductive and mixed hearing losses, bilateral fitting and singlesided deafness.

### Indications for use

The Ponto bone anchored hearing system (Ponto sound processors and implant system) is indicated 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

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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 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).

# Technological Characteristics

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 modified abutment component within the Ponto bone anchored hearing system has the same technological characteristics as the previously cleared abutments. The modified Ponto bone anchored hearing system is the same device as the cleared Ponto bone anchored hearing system (K112053, K121228, K132775) except for the following modification:

- . Expansion of the abutment product line from 6mm, 9mm and 12mm to add a 14 mm abutment
### Performance Data

The modified device has been tested in comparison to the previously cleared device to verify the performance to support safety and effectiveness. Performance data. including bench testing of mechanical forces, show that the modified device is as safe and effective as the previously cleared device.

### Substantial Equivalence

The modified Ponto bone anchored hearing system has the same intended use and indications, the same principles of operation, and the same technological characteristics as the previously cleared Ponto bone anchored hearing system (K112053, K121228, K132775). The only difference is the addition of a longer abutment to the product range. Performance data demonstrates that the modified device is as safe and effective as the previously cleared Ponto bone anchored hearing system and will perform as intended during use. Thus, the modified Ponto bone anchored hearing system is substantially equivalent to its predicate device.