PONTO PRO POWER
Device Facts
| Record ID | K103594 |
|---|---|
| Device Name | PONTO PRO POWER |
| Applicant | Oticon Medical AB |
| Product Code | LXB · Ear, Nose, Throat |
| Decision Date | Jun 15, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3302 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence, Pediatric |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K103594 · Jun 15, 2011 | PONTO PRO POWER | Oticon Medical AB | Clinical performance data from experienced users of the predicate device (Baha Intenso) | The sponsor conducted a comparative study of 20 experienced users of the predicate device to evaluate the performance of the Ponto Pro Power in terms of aided thresholds, speech perception, and user satisfaction/preference. | Comparative study; Experienced users; Speech perception; User satisfaction |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Unpublished study of Ponto Pro Power vs. Baha Intenso; Comparative study of experienced users; Follow-up/Duration: Subjects had used Baha Intenso for at least 4 months | 20 experienced users of Baha Intenso (18 with conductive/mixed hearing loss, 2 with single-sided deafness); Sample Size: 20 | Baha Intenso (K081606) | Aided thresholds, speech perception in quiet, speech perception in noise, APHAB, SSQ, user satisfaction, device preference |
Indications for Use
The Ponto Pro Power sound processor is intended for improvement of hearing for patients with conductive and mixed losses, bilateral fitting and single sided deafness.
Device Story
Ponto Pro Power is a bone-conduction hearing aid; connects to surgically implanted abutment behind ear or head band. Device captures ambient sound; processes via digital signal processing (DSP) algorithms; transmits vibrations through skull to cochlea. Features include Wind Noise Reduction, Dynamic Feedback Cancellation, Automatic Gain Control, Speech Guard, and Automatic Multiband Adaptive Directionality. Operated by patient or clinician via Genie Medical software for fitting. Data logging tracks usage/settings for optimization. Benefits include improved speech intelligibility and comfort in noisy environments. Clinicians use output to adjust gain/settings to patient audiogram. Device provides alternative to air-conduction CROS systems.
Clinical Evidence
Clinical study of 18 subjects with conductive/mixed hearing loss (mean age 58.1). Compared Ponto Pro Power to Baha Intenso. Endpoints: aided thresholds, speech perception in quiet/noise, APHAB, SSQ, and user questionnaires. Results showed no significant differences in aided thresholds or speech reception between devices. BC In-situ Audiometry validated against conventional audiometry in 25 patients; mean difference < 5 dB, confirming clinical sensitivity.
Technological Characteristics
Bone-conduction sound processor; PEEK coupling; zinc-air battery; 125 Hz-8 kHz frequency response; 47 dB max gain at 1600 Hz. Features digital signal processing, automatic gain control, multiband adaptive directionality, and feedback cancellation. Software-based fitting via Genie Medical. Connectivity: proprietary coupling to bone-anchored implants.
Indications for Use
Indicated for patients with conductive or mixed hearing loss (PTA BC threshold ≤ 55 dB HL at 0.5, 1, 2, 3 kHz); bilateral fitting for symmetric conductive/mixed loss (BC threshold difference < 10 dB avg or < 15 dB individual); single-sided deafness (profound sensorineural loss in one ear, normal hearing in opposite ear with AC threshold ≤ 20 dB HL); or patients indicated for AC CROS who cannot/will not use AC CROS. 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
Submission Summary (Full Text)
{0}------------------------------------------------
K103594
JUN 1 5 2011
# SECTION 2. SUMMARY AND CERTIFICATION
## A. 510(K) SUMMARY
## Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Oticon Medical summary for the Ponto Pro Power bone anchored sound processor.
SUBMITTER'S NAME: ADDRESS:
CONTACT PERSON: TELEPHONE NUMBER: FAX NUMBER: E-MAIL: DATE OF SUBMISSION: Oticon Medical AB Ekonomivägen 2 SE-436 33 Askim Sweden
Ulrika Nielsen +46 31 748 61 66 +46 31 687 756 uln@oticonmedical.se December 1, 2010
- Identification of device 1.
Proprietary Name: Common Name: Classification Status: Product Code:
Ponto Pro Power Hearing Aid, Bone Conduction Class II per regulations 21 CFR § 874.3300 LXB
#### 2. Equivalent devices
Oticon Medical believes that the Ponto Pro Power, regarding intended use, function, procedure and fitting, is substantially equivalent to the Ponto and Ponto Pro cleared in K082108 and K090996. The indications for use are equivalent to the Baha® Intenso™ cleared in K081606. The ability to measure bone-conduction thresholds directly via pure tones generated by the sound processor (BC In-Situ Audiometry), is substantially equivalent to the Baha® BP 100 in K090720.
{1}------------------------------------------------
#### 3. Description of the device
Ponto Pro Power is a bone conduction hearing aid which is connected to an implant with a skin penetrating abutment which has 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. Ponto Pro Power has a coupling so that it can easily be connected and disconnected from the abutment by the user or alternatively from a head band accessory, to function as a conventional bone conductor. Using a computer based fitting system, Genie Medical; Ponto Pro Power can be adjusted to the patient's individual hearing requirements. Ponto Pro Power contains a number of advanced features:
- · Wind Noise Reduction Depending on the wind noise level, sounds will be attenuated. The more wind, the more attenuation. In Ponto Pro Power the Wind Noise Reduction system will - in addition force the instrument into Omni directionality mode.
- · Feedback Management System The Feedback Management System consists of two parts: Feedback Manager and Dynamic Feedback Cancellation.
- The Feedback Manager is a tool in Genie Medical that measures and applies feedback limits in O the sound processor. The feedback limits are set to prevent static feedback and to facilitate the full use of the entire range of the volume control without feedback.
- Dynamic Feedback Cancellation (DFC) is a feature in the sound processor that constantly checks 0 for the presence of acoustic feedback. When feedback is detected, the DFC system phase cancels the feedback signal. DFC is designed to minimize the risk of feedback by adapting to sudden acoustical changes.
- · Automatic Gain Control Ponto Pro Power has an Automatic Gain Control that adjusts the gain to the environment. The Automatic Gain Control can work both over the whole frequency range and in each of the 10 frequency bands. There is an output AGC that ensures there is no distorted peak clipped signal at saturation level of the instrument. A peak clipped signal distorts the sinus signal. By avoiding this distortion, increased sound comfort is achieved.
- · Speech Guard Speech Guard is a signal processing system that works by maintaining linear processing as much as possible, but at the same time responding instantaneously to rapidly occurring environmental sounds - Speech Guard is designed to produce less distortion than traditional compression systems.
- BC In-situ Audiometry BC In-situ Audiometry is a tool in Genie Medical for measuring the . patient's bone conduction hearing thresholds directly via the sound processor.
- · Automatic Multiband Adaptive Directionality The system analyzes information from various environmental detectors and automatically chooses one of the three different directionality modes with the aim of automatically offering an improved speech to noise ratio in adverse listening situations. The directionality modes are Omni, Split Directionality and Full Directionality.
- · Tri-state Noise Reduction The Tri-state Noise Reduction system continuously analyzes the environment and aims at providing the appropriate amount of attenuation in different listening environments. It includes the detection of speech, environmental background noise and wind noise. The system automatically moves seamlessly between the different states. The aim of this system is to provide some degree of comfort in noisy environments while preserving the information most important for speech intelligibility.
- · Data Logging Data Logging permits the Ponto Pro Power to memorize listening levels, usage time, user settings and system states. The data can be analyzed externally, providing the audiologist and the patient with valuable information can be used to adjust the system settings in order to optimize patient comfort and speech intelligibility in any complex listening situation.
- · Learning Volume Control The Learning Volume Control enables the hearing system to adjust automatically to patient preferences over time. Different listening situations and preferred volume settings are memorized. The system continuously analyzes listening situations and automatically adjusts the volume to the memorized preferred setting. In this way the system assists to get the preferred volume for the patient without his/hers manual adjustment of the volume control.
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).
{2}------------------------------------------------
#### 4. Intended Use
The Ponto Pro Power sound processor is intended for improvement of hearing for patients with conductive and mixed losses, bilateral fitting and single sided deafness.
| Characteristics | Ponto Pro | Ponto Pro | BP100 | Baha<br>Intenso™ | S/Eq |
|---------------------|--------------------|--------------------|--------------------|--------------------|------|
| | Power | | | | |
| Design | Bone conduction | Bone conduction | Bone conduction | Bone conduction | Yes |
| | sound processor | sound processor | sound processor | sound processor | |
| | connected to an | connected to an | connected to an | connected to an | |
| | implant which | implant which | implant which | implant which | |
| | has been | has been | has been | has been | |
| | surgically placed | surgically placed | surgically placed | surgically placed | |
| | in the bone | in the bone | in the bone | in the bone | |
| | behind the ear | behind the ear | behind the ear | behind the ear | |
| | | | | | |
| Indications for use | Improvement of | Improvement of | Improvement of | Improvement of | Yes |
| | hearing for | hearing for | hearing for | hearing for | |
| | patients with | patients with | patients with | patients with | |
| | conductive and | conductive and | conductive and | conductive and | |
| | mixed hearing | mixed hearing | mixed hearing | mixed hearing | |
| | losses, bilateral | losses, bilateral | losses, bilateral | losses, bilateral | |
| | fitting and single | fitting and single | fitting and single | fitting and single | |
| | sided deafness | sided deafness | sided deafness | sided deafness | |
| | | | | | |
| Pure tone average | Better than or | Better than or | Better than or | Better than or | Yes |
| bone conduction | equal to 55 dB | equal to 45 dB | equal to 45 dB | equal to 55 dB | |
| threshold of the | HL (measured at | HL (measured at | HL (measured at | HL (measured at | |
| indicated ear for | 0.5, 1, 2, 3) | 0.5, 1, 2, 3 kHz) | 0.5, 1, 2, 3 kHz) | 0.5, 1, 2, 3) | |
| patients with | | | | | |
| conductive or | | | | | |
| mixed hearing loss | | | | | |
| Material | Sound processor | Sound processor | Sound processor | Sound processor | Yes |
| | coupling: PEEK | coupling: PEEK | coupling: PEEK | coupling: PEEK | |
| Power requirement | Zinc-air battery | Zinc-air battery | Zinc-air battery | Zinc-air battery | Yes |
| Max gain at 1600 | 47 dB | 33 | 33 | 45 dB | Yes |
| Hz | | | | | |
| Frequency response | 125 Hz-8 kHz | 125 Hz - 8 kHz | 250 Hz-7 kHz | 250 Hz - 7 kHz | Yes |
| Sound processing | Digital | Digital | Digital | Digital | Yes |
| Patient fitting | Individual | Individual | Individual | Individual | Yes |
| | adjustment to | adjustment to | adjustment to | adjustment to | |
| | patient | patient | patient | patient | |
| | audiogram and | audiogram and | audiogram and | audiogram and | |
| | needs by a | needs by a | needs by a | needs by | |
| | computer based | computer based | computer based | potentiometers | |
| | fitting system | fitting system | fitting system | adjusted by the | |
| | used by the | used by the | used by the | audiologist using | |
| | audiologist. | audiologist. | audiologist. | a screwdriver. | |
| Manufacturer | Oticon Medical | Oticon Medical | Cochlear Bone | Cochlear Bone | Yes |
| | AB | AB | Anchored | Anchored | |
| | | | Solutions AB | Solutions AB | |
| K-number | No number yet | K090996 | K090720 | K081606 | |
#### 5. Technological characteristics, comparison to predicate device
{3}------------------------------------------------
#### 6 Discussion of testing
Testing of the Ponto Pro Power has been performed to verify design criteria and device performance with respect to mechanical, electroacoustical and software properties.
Published data in the literature support the safety and efficacy of the predicate device, Baha Intenso for patients with average bone-conduction thresholds of < 55 dB HL. Bench performance data has verified the Ponto Pro Power to be equivalent to the predicate device in terms of device gain and maximum force output. Therefore Ponto Pro Power is considered to successfully fit the same patient population; i.e. those with bone-conduction thresholds of < 55 dB HL.
Verification of the safety and effectiveness of the new sound processing features introduced for Ponto Pro Power: Wind noise reduction. Dynamic Feedback Cancellation. Speech Guard and BC In-situ Audiometry include bench performance testing as well as clinical evaluation. Bench performance data of the wind noise reduction feature verify that when exposed to a preset air flow the device responds to the air flow/wind by reducing overall gain and switching mode, respectively. Bench performance data on the Dynamic Feedback Cancellation (DFC) feature show that feedback is identified and cancelled out by the DFC system without artifacts being introduced. Bench testing of the Speech guard feature include testing of the behavior of Speech Guard at different gain settings, input levels, and different types of noise input and shows that the device is able to maintain linear processing as much as possible, while at the same time responding instantaneously to rapidly occurring environmental sounds. The bench data confirms the effectiveness of the sound processing features and ensure that no negative effects are introduced.
Clinical data include comparisons with the predicate device Baha Intenso (K081606). In an unpublished study funded by the submitter, performance data of both instruments were collected from 20 experienced users of Intenso, 18 subjects had mixed hearing losses and 2 were single-sided deaf. Only results from the homogenous group of the 18 subjects with conductive and mixed hearing losses were analyzed. 5 subjects were male and 13 female. The age range between 17 years and 75 years, average age of the subjects was 58.1 years, SD 14.53 years. All subjects had used Baha Intenso for at least 4 months and were tested with the Intenso prior to testing with the Ponto Pro Power . Performance of both devices was evaluated objectively in terms of aided thresholds, speech perception in quiet and speech perception in noise. Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Speech Spatial and Quality Scale of Hearing (SSO). In addition, user experiences, user satisfaction, and device preference among subjects were probed via questionnaires. The aided thresholds were essentially similar for both devices; no significant differences were observed between the two devices.
Ponto Pro Power was verified to be substantially equivalent to the predicate device Baha Intenso, both concerning subjective evaluation on wind noise and feedback and in terms of speech reception threshold in quiet and speech reception threshold in noise.
To verify the effect of BC In-situ Audiometry conventional unmasked BC hearing thresholds was measured with two methods for a group of 25 hearing impaired patients, an audiometer using a RadioEar B-71 bone conduction transducer and the BC In-situ Audiometry tool in Genie Medical via the sound processor on the patients abutment. The difference between both measurement methods is on average less than 5 dB. Taking audiometric step size (5 dB) and size of population into account, both measurement methods can be regarded as similarly sensitive for audiometric BC threshold measurements.
#### 7 Conclusion
Based on the comparison to the predicate devices, the Oticon Medical Ponto Pro Power, is substantially equivalent to devices already on the market cleared by the 510(k) process.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration. 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Oticon Medical AB c/o Ms. Ulrika Nielson Ouality and Regulatory Manager Ekonomiv. 2 SE-436 33 Askim Sweden
JUN 1 5 201
Re: K103594
Trade/Device Name: Ponto Pro Power Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid, Bone Conduction Regulatory Class: Class II Product Code: LXB Dated: May 3, 2011 Received: May 6, 2011
Dear Ms. Nielson:
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.
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
{5}------------------------------------------------
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 (QS) 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), 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.fdagov/MedicalDevices/Safety/ReportaProblem/default.h1m 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erlacher. mf.
Malvina B. Eydelman, M Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
{6}------------------------------------------------
## B. INDICATIONS FOR USE
510(k) Number:
Device Name: Ponto Pro Power
### Indications for Use:
The Ponto Pro Power 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 of the indicated ear should be better than or equal to 55 dB HL (measured at 0.5, 1, 2 and 3 kHz)
- Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed . hearing loss. The difference between the left and right sides' BC thresholds should be less than 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 Pro Power sound processor is intended to be connected to the Oticon Medical bone anchored implant system or to the Baha@ Abutment snap coupling from Cochlear Bone Anchored Solutions AB (ref no. 90410, 90305, 90434, 90480).
Over -The-Counter Use Prescription Use X OR (Part 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
### Concurrence of CDRH, Office of Device Evaluation (ODE)
6
Van Raalt
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear Nose and Throat Devices
510(k) Number K103594
