(65 days)
Not Found
No
The summary focuses on the mechanical and surgical aspects of a bone-anchored hearing system and a modified surgical drilling technique. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a "Bone Anchored Hearing System" which is intended to address hearing loss, a medical condition, by amplifying sound. This re-establishes a function of the body (hearing), which aligns with the definition of a therapeutic device.
No
The Ponto Bone Anchored Hearing System is a hearing aid designed to treat hearing loss by transmitting sound through bone conduction. Its purpose is amplification and sound transmission, not to provide diagnostic information about a patient's condition.
No
The device description explicitly states it consists of an external sound processor unit and an implant with a skin penetrating abutment, which are hardware components. The 510(k) is primarily focused on a modification to the surgical drilling procedure and associated instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Ponto Bone Anchored Hearing System is a device that transmits sound vibrations directly to the cochlea through bone conduction. It involves an external sound processor and an implanted component.
- Intended Use: The intended use is to treat hearing loss by providing amplification of sound through bone conduction. It does not involve testing samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic testing.
Therefore, the Ponto Bone Anchored Hearing System is a therapeutic device for hearing loss, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
MAH
Device Description
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 surqically 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The implant is placed in or around the mastoid region of the skull on either one or both sides.
Indicated Patient Age Range
The placement of a bone anchored implant is contraindicated for patient below the age of 5.
MONO surgical procedure is indicated for: Adult patients (18 years and above) with normal anatomy and expected bone thickness of at least 5mm, where no complications during surgery are expected. Use of MONO surgical technique is contraindicated for children and patients with expected bone thickness below 5 mm.
Intended User / Care Setting
Surgical procedure performed by an ENT surgeon.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical bench tests were performed to compare the technical performance of the new drill against its precursors, that have proven to perform well in a clinical setting.
Comparative testing to install 4 mm Ponto implant (Ø4.5 mm) in artificial bone using the MONO Surgery Kit and the predicate devices were performed. The testing included heat generation, insertion torque, installation turns, seating and measurements of ISQ-value at implant level. The results were according to the requirements and confirmed equivalence with the predicate drills/drill protocol.
The above-mentioned tests confirm that the MONO procedure and MONO Surgery Kit are as safe and efficient as the predicate MIPS procedure and MIPS Surgery Kit (K152067). In all instances, the modified instruments functioned as intended and the performance was as expected. Hence, it has been concluded that further testing will not raise new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 4, 2021
Oticon Medical AB Carolina Wessling RA Manager Datavagen 37B Askim, SE-436 32 Sweden
Re: K203807
Trade/Device Name: Ponto Bone Anchored Hearing System, MONO Surgery Kit Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: MAH
Dear Carolina Wessling:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 3, 2021. Specifically, FDA is updating this SE Letter (e.g., typo in the trade/device name).
Please note that the 510(k) submission was not re-reviewed. For questions this letter please contact Shu-Chen Peng, Ph.D., OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6481, Shu-Chen.Peng@fda.hhs.gov.
Sincerely,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 3, 2021
Oticon Medical AB Carolina Wessling RA Manager Datavagen 37B Askim, SE-436 32 Sweden
Re: K203807
Trade/Device Name: Pronto Bone Anchored Hearing System, MONO Surgery Kit Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: MAH Dated: February 2, 2021 Received: February 5, 2021
Dear Carolina 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
2
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shu-Chen Peng
Shu-Chen Peng, Ph.D. Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K203807
Device Name
Ponto Bone Anchored Hearing System
Indications for Use (Describe)
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).
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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4
510(k) SUMMARY
Oticon Medical AB's Ponto Bone Anchored Hearing System
Ponto Implant System, MONO Surgery Kit
Submitter: Oticon Medical AB Datavägen 37B SE-436 32 Askim Sweden
Phone: +46 31 748 61 00 Facsimile: +46 31 687 756
Contact Person: Carolina Anker Wessling Date Prepared: December 22, 2020
510(k) number: K203807
Name of Device: Ponto Bone Anchored Hearing System, Ponto Implant System, MONO Surgery Kit,
Common or Usual Name: Hearing aid, bone conduction
Classification Name: Hearing aid, bone conduction, implanted
Regulatory Class: 21 CFR §874.3300, Class II
Product Code: MAH
Predicate Devices
| Predicate Device | 510(k) no. | Manufacturer |
|---|---|---|
| Ponto Bone Anchored Hearing | ||
| System | K152067 | Oticon Medical AB |
Device Description and purpose of the 510(k) notice
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
5
surqically 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.
Intended Use / Indications for Use
Intended use
The Ponto Bone Anchored Hearing System's intended use is for improvement of hearing for patients with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single-sided deafness.
Indications for use
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 3 and 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.
6
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).
Summary of Technological Characteristics
Minor modifications have been made to the drills previously cleared in 510(k) K152067. In the MONO Surgery Kit, the guide drill is removed, and the widening drill is modified to enable a single drill step to prepare the osteotomy for Ponto implant installation.
The MONO drill is provided in a kit packaging together with Cannula, Insertion indicator and Soft healing cap. The Cannula, Insertion indicator and Soft healing cap components included in the MONO Surgery Kit are identical to those included in the previously cleared MIPS Surgery Kit (K152067).
The technological principle and characteristics of the Ponto Bone Anchored Hearing System, Ponto Implant System, remain unchanged from the original design (most recently cleared in K152067). No changes have been made to the implant components within the Ponto Bone Anchored Hearing System compared to previously cleared K152067.
Performance data
Pre-clinical bench tests were performed to compare the technical performance of the new drill against its precursors, that have proven to perform well in a clinical setting.
Comparative testing to install 4 mm Ponto implant (Ø4.5 mm) in artificial bone using the MONO Surgery Kit and the predicate devices were performed. The testing included heat generation, insertion torque, installation turns, seating and measurements of ISQ-value at implant level. The results were according to the requirements and confirmed equivalence with the predicate drills/drill protocol.
The above-mentioned tests confirm that the MONO procedure and MONO Surgery Kit are as safe and efficient as the predicate MIPS procedure and MIPS Surgery Kit (K152067). In all instances, the modified instruments functioned as intended and the performance was as expected. Hence, it has been concluded that further testing will not raise new issues of safety and efficacy.
7
Substantial Equivalence Conclusions
The Ponto Bone Anchored Hearing System, including MONO Surgery Kit, is as safe and effective as the predicate Ponto Bone Anchored Hearing System (K152067). The Ponto Bone Anchored Hearing System has the same intended use and indications as previously cleared in K152067. Further, no changes have been made to the overall characteristics or principles of operation of the Ponto Bone Anchored Hearing System compared to the predicate device (K152067).
The minor technological differences between the MONO Surgery Kit and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the installation of Ponto Bone Anchored Hearing System implants using the MONO procedure is as safe and effective as the predicate installation procedures (K152067).
Accompanying documentation provide information on selection of surgical technique suited for the individual patient. The MONO Surgery Kit and MONO procedure do not alter the intended use of the Ponto Bone Anchored Hearing System and do not affect the safety and effectiveness of the Ponto Bone Anchored Hearing System when used as labelled.
Thus, the Ponto Bone Anchored Hearing System, including MONO Surgery Kit, is substantially equivalent to the previously cleared Ponto Bone Anchored Hearing System (K152067).
8
Substantial Equivalence Chart
| Predicate 510(k) K152067 | This 510(k) K203807 | |
|---|---|---|
| Manufacturer | Oticon Medical AB | Oticon Medical AB |
| Intended Use | The Ponto 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's intended | |
| use is for improvement of hearing for patients with | ||
| conductive or mixed hearing losses, whether | ||
| unilaterally or bilaterally fitted, or for those with single- | ||
| sided deafness. | ||
| 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). | 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 3 and | ||
| 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) | ||
| Technological | ||
| characteristics / | ||
| anatomical sites | 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. | Same / No change | |
| Predicate 510(k) K152067 | This 510(k) K203807 | |
| Implant system | ||
| components | Implants | |
| Abutments | ||
| Connection screw | ||
| Healing cap | ||
| Cover screw | Same / No change | |
| Intended use; Implant | The implants are intended to be placed in bone tissue | |
| for long term use (more than 25 years). The implants | ||
| are intended to integrate with the bone tissue and | ||
| provide a reliable anchorage for a sound processor. | Same / No change | |
| Compatible sound | ||
| processors | All Oticon Medical sound processors and selected | |
| sound processors from Cochlear Bone Anchored | ||
| Solutions. | ||
| See Ponto labeling for compatible Baha sound | ||
| processor models. | Same / No change | |
| Surgical instruments | Single use drills: | |
| Linear incision drill (Guide drill / Wide Countersink) | ||
| MIPS Surgery Kit | ||
| Reusable instruments | Single use drills: | |
| Linear incision drill (Guide drill / Wide Countersink) | ||
| MIPS Surgery Kit | ||
| MONO Surgery Kit | ||
| Reusable instruments | ||
| Implant system | ||
| installation | Surgical procedure performed by an ENT surgeon. | Same / No change |
| Procedures for Ponto | ||
| implant installation | Three (3) alternative procedures available: | |
| Linear incision, one-stage | ||
| Linear incision, two-stage | ||
| MIPS | Same, with addition of one (1) alternative procedure: | |
| MONO | ||
| Selecting procedure | Linear incision, single-stage surgery is indicated for: Adult | |
| patients with normal bone quality and thickness above 3 mm, | ||
| where no complications during surgery are expected. | ||
| Children with normal bone quality and a bone thickness above | ||
| 4 mm (typically 12 years or older) provided that age, | ||
| development status and other known factors have been | ||
| considered and found suitable for single-stage surgery. | ||
| Linear incision, two-stage surgery is recommended | ||
| for/when: Adult patients with an expected bone depth below 3 | ||
| mm or expected poor bone quality. (Reasons for expecting | ||
| poor bone quality or thin bone may for example include disease | ||
| or history of irradiation.) | ||
| Children with a bone thickness below 4 mm, or where age | ||
| development status or other factors make single-stage surgery | ||
| unsuitable. | ||
| An implant is placed in association with the removal of an | ||
| acoustic neuroma. | ||
| Contact with the dura mater or the wall of the sigmoid sinus is | ||
| expected, or if there is any risk of complications. | ||
| MIPS surgical procedure is indicated for: Adult patients with | ||
| normal bone quality and bone thickness above 3 mm, where no | ||
| complications during surgery are expected. | ||
| Children with normal bone quality and a bone thickness above | ||
| 4 mm (typically 12 years or older) provided that age, | ||
| development status and other known factors have been | ||
| considered and found suitable for single-stage surgery. | ||
| Patients, as per above, with a skin thickness of 12 mm or less. | Same, with addition of: | |
| MONO surgical procedure is indicated for: Adult patients (18 | ||
| years and above) with normal anatomy and expected bone | ||
| thickness of at least 5mm, where no complications during | ||
| surgery are expected. | ||
| Patients, as per above, with a skin thickness of 12 mm or less. | ||
| Use of MONO surgical technique is contraindicated for children | ||
| and patients with expected bone thickness below 5 mm. | ||
| Implant material | Titanium, grade 4 | Same / No change |
| Implant surface | Smooth titanium surface | |
| Laser ablation applied to parts of the thread valleys. | Same / No change | |
| Predicate 510(k) K152067 | This 510(k) K203807 | |
| Implant manufacturing | Machine turning | |
| Laser ablation | Same / No change | |
| Implant cutting | ||
| properties | Self-tapping | Same / No change |
| Implant to abutment | ||
| interface | Hexagon fit | Same / No change |
| Means of attaching the | ||
| abutment to the implant | The abutment is fastened to the implant via an internal | |
| connection screw. | Same / No change | |
| Packaging (sterile) | Peel open sterile pack | Same / No change |
| Sterilization method | Pre-sterilized by radiation (e-beam) sterilization | Same / No change |
| Single Use or Reusable | Single Use | Same / No change |
| Shelf Life | 5 years | Same / No change |
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