(112 days)
Not Found
No
The document describes a bone conduction hearing aid and its components, focusing on its physical design, intended use, and fitting process. There is no mention of AI or ML technologies being used for sound processing, adaptation, or any other function. The fitting is described as being adjusted to the patient's individual hearing requirements using a computer-based system, which is standard for modern hearing aids and does not inherently imply AI/ML.
Yes
The device is a bone conduction-type hearing aid, which is used to amplify sound for individuals with hearing loss, directly addressing a health condition.
No
This device is described as a "bone conduction-type hearing aid" that processes and transmits sound. Its stated purpose is to provide "amplification of the sound" and adjust to "patient's individual hearing requirements," which are therapeutic functions, not diagnostic. While it relies on existing hearing measurements for proper fitting, it does not perform those measurements itself.
No
The device description explicitly states it is a "bone conduction-type hearing aid" and describes physical components like a "sound processor," "implant," "abutment," and "head band accessories." It also mentions being connected to existing hardware systems. This indicates it is a hardware device with associated software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The device description clearly states that the Ponto Pro is a bone conduction-type hearing aid that transmits vibrations through the skull bone to the cochlea. It does not analyze any biological samples (like blood, urine, tissue, etc.).
- The intended use is for hearing amplification. The indications for use describe patient populations with specific types of hearing loss and how the device helps them hear better. This is a therapeutic function, not a diagnostic one.
- The device description focuses on mechanical and acoustic function. The description details how the device works by transmitting vibrations and how it connects to an implant. It does not mention any analytical processes or the detection of biomarkers.
Therefore, the Ponto Pro is a medical device, specifically a hearing aid, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ponto Pro 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 for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2 and 3 kHz).
- I 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.
- l 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 then be better than 20 dB HL (measured at 0.5. 1, 2 and 3 kHz).
The placement of a bone anchored implant is contraindicated for patients below the age of 5.
The Ponto Pro sound processor is intended to be connected to the Oticon Medical bone anchored implant system or to the Baha® Abutment snap coupling from Cochlear BAS. In addition, the Oticon Medical abutments can be used for connection of the Baha® sound processors with snap coupling from Cochlear BAS (Baha Divino®, Baha IntensoTM, Baha Cordelle II, Baha BP100),
Product codes
LXB
Device Description
The Ponto Pro is a bone conduction-type hearing aid. The Ponto Processor is connected to an implant with a skin penetrating abutment which as been 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 Ponto Pro sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. The Ponto Pro can alternatively be connected to head band accessories, to function as a conventional bone conductor. Using a computer based fitting system the Ponto Pro can be adjusted to the patient's individual hearing requirements. The sound processor is intended to work with the Oticon Medical bone anchored implant system or the Baha® Abutment snap coupling from Cochlear BAS (ref no. 90410, 90305, 90434, 90480). In addition, the Oticon Medical abutments can be used for connection of the Baha® sound processors with snap coupling from Cochlear BAS (Baha Divino®, Baha Intenso"" Baha Cordelle II, Baha BP100; ref no. 90500, 90510, 90511, 90502, 90512, 90503, 90513, 90730, 90731, 90732, 90733, HBC 400-0, HCB 401-0, HCB 402-0, 91301, 91302, 91303, 91304, 91305).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The placement of a bone anchored implant is contraindicated for patients below the age of 5.
Intended User / Care Setting
Not Found
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)
Testing of the Ponto Pro include functional testing and software validation. These tests verify that the Ponto Pro is functionally equivalent to the OBC, why we have come to the conclusion that further testing will not raise new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
SECTION 2. SUMMARY AND CERTIFICATION
510(K) SUMMARY ব
JUL 2 9 2002
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Oticon Medical summary for the Ponto Pro bone anchored sound processor
| SUBMITTER'S NAME: | Oticon Medical AB |
|---|---|
| ADDRESS: | Ekonomiv. 2 |
| SE-436 33 Askim | |
| Sweden | |
| CONTACT PERSON: | Karolin Isberg |
| TELEPHONE NUMBER: | +46 31 748 6153 |
| FAX NUMBER: | +46 31 687 756 |
| E-MAIL: | kai@oticonmedical.se |
| DATE OF SUBMISSION: | April 6, 2009 |
1. Identification of device
Proprietary Name: Ponto Pro Common Name: Hearing Aid, Bone Conduction Classification Status: Class II per regulations 21 CFR § 874.3300 Product Codes: LXB
2. Equivalent devices
Oticon Medical believes that the Ponto Pro, regarding intended use, function and procedure, is substantially equivalent to the OBC cleared in 510(k) K082108. has substantially equivalent fitting technology as air conduction hearing aids with digital sound processing (exempt from 510(k)) and has substantially equivalent accessories for direct audio input as the Baha® Divino cleared in 510(k) K042017.
3. Description of the Device
The Ponto Pro is a bone conduction-type hearing aid. The Ponto Processor is connected to an implant with a skin penetrating abutment which as been 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 Ponto Pro sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. The Ponto Pro can alternatively be connected to head band accessories, to function as a conventional bone conductor. Using a computer based fitting system the Ponto Pro can be adjusted to the patient's individual hearing requirements. The sound processor is intended to work with the Oticon Medical bone anchored implant system or the Baha® Abutment snap coupling from Cochlear BAS (ref no. 90410, 90305, 90434, 90480). In addition, the Oticon Medical abutments can be used for connection of the Baha® sound processors with snap coupling from Cochlear BAS (Baha Divino®, Baha Intenso"" Baha Cordelle II, Baha BP100; ref no. 90500, 90510, 90511, 90502, 90512, 90503, 90513, 90730, 90731, 90732, 90733, HBC 400-0, HCB 401-0, HCB 402-0, 91301, 91302, 91303, 91304, 91305).
1
4. Intended use
The Ponto Pro sound processor is intended for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single sided deafness.
ડ. Technological characteristics, comparison to predicate device
| Characteristics | Ponto Pro | OBC | BAHA Divino | Air conduction
Hearing Aids
with digital
sound processing | S/Eq |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------|
| Design | Bone conduction
sound processor
connected to an
implant which has
been surgically
placed in the bone
behind the ear | Bone conduction
sound processor
connected to an
implant which has
been surgically
placed in the bone
behind the ear | Bone conduction
sound processor
connected to an
implant which has
been surgically
placed in the bone
behind the ear | Air conduction
sound processor
placed behind the
ear or in the ear
canal. | Yes |
| Intended use | Improvement of
hearing for
patients with
conductive and
mixed hearing
losses, bilateral
fitting and single
sided deafness | Improvement of
hearing for
patients with
conductive and
mixed hearing
losses, bilateral
fitting and single
sided deafness | Improvement of
hearing for
patients with
conductive and
mixed hearing
losses, bilateral
fitting and single
sided deafness | Improvement of
hearing | Yes |
| Material | Sound processor
coupling: PEEK
Implant: Titanium | Sound processor
coupling: PEEK
Implant: Titanium | Sound processor
coupling: PEEK
Implant: Titanium | Multiple | Yes |
| Power
requirement | Zinc-air battery | Zinc-air battery | Zinc-air battery | Zinc-air battery | Yes |
| Max gain | 33dB | 33dB | 33dB | N/A | Yes |
| Frequency
response | 125 Hz-8 kHz | 125 Hz - 8 kHz | 125 Hz - 8 kHz | N/A | Yes |
| Sound processing | Digital | Digital | Digital | Digital | Yes |
| Patient fitting | Individual
adjustment to
patient audiogram
and needs by a
computer based
fitting system used
by the audiologist | Individual
adjustment to
patient audiogram
and needs by a
computer based
fitting system at
the manufacturer
on request from
the audiologist. | Individual
adjustment to
patient audiogram
and needs by
potentiometers
adjusted by the
audiologist using a
screwdriver. | Individual
adjustment to
patient audiogram
and needs by a
computer based
fitting system used
by the audiologist | Yes |
| Accessories | Various
accessories for
direct audio input
(DAI) | Various
accessories for
direct audio input
(DAI) | Various
accessories for
direct audio input
(DAI) | N/A | Yes |
| Manufacturer | Oticon Medical
AB | Oticon Medical
AB | Entific Medical
Systems AB | N/A | |
| K-number | No number yet | K082108 | K042017 | Exempt from
510(k) | |
Comnarison table
6. Discussion of testing
Testing of the Ponto Pro include functional testing and software validation. These tests verify that the Ponto Pro is functionally equivalent to the OBC, why we have come to the conclusion that further testing will not raise new issues of safety and efficacy.
7. Conclusion
Based on the comparison to the predicate devices, the Oticon Medical Ponto Pro, is substantially equivalent to devices already on the market, both cleared by and exempt from the 510(k) process, and presents no new concerns about safety and effectiveness.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Oticon Medical AB C/O Karolin Isberg Quality and Regulatory Affairs Manager Ekomomiv. 2 SE-436 33 Askim Sweden
JUL 2 9 2009
Re: K090996
Trade/Device Name: Ponto Pro Bone Anchored Sound Processor with Accessories Regulation Number: 21 CFR 874,3300 Regulation Name: Hearing Aid, Bone Conduction Regulatory Class: Il Product Code: LXB Dated: July 10, 2009 Received: July 14, 2009
Dear Ms. Isberg:
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.
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 801); 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address. http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Ra. An. no/p
Malvina B. Eydelman, M.I Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Kojo 996
Indications for Use
510(k) Number (if known): K090996
Device Name: Ponto Pro
Indications For Use:
The Ponto Pro 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 for the indicated ear should be better than 45 dB HL (measured at 0.5, 1, 2 and 3 kHz).
- I 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.
- l 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 then be better than 20 dB HL (measured at 0.5. 1, 2 and 3 kHz).
The placement of a bone anchored implant is contraindicated for patients below the age of 5.
The Ponto Pro sound processor is intended to be connected to the Oticon Medical bone anchored implant system or to the Baha® Abutment snap coupling from Cochlear BAS. In addition, the Oticon Medical abutments can be used for connection of the Baha® sound processors with snap coupling from Cochlear BAS (Baha Divino®, Baha IntensoTM, Baha Cordelle II, Baha BP100),
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jams K. Kane ph.D
Page 1 of 1
(Division Sign-Off) vision of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K090996