(114 days)
Not Found
No
The summary does not mention AI or ML, and the device description focuses on hardware and basic signal processing for hearing amplification.
Yes
The document explicitly states the device is intended for "treatment of patients who have conductive or mixed hearing loss... and for those who have Single-Sided Deafness (SSD)". This describes a therapeutic function.
No
Explanation: The device is described as a sound processor intended for the treatment of hearing loss by amplifying sound and transmitting it to the inner ear. Its function is to provide an alternative pathway for sound for patients who may not benefit from air-conduction hearing aids, effectively treating a condition, rather than diagnosing it.
No
The device description explicitly states it is a "Sound Processor" that functions by combining an external sound processor with an abutment and a titanium implant placed in the skull. It also mentions a rechargeable lithium-ion battery pack. These are all hardware components, indicating it is not a software-only device.
Based on the provided text, 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 Function: The Cochlear™ Baha® 5 SuperPower Sound Processor is a hearing aid system that transmits sound directly to the inner ear via bone conduction. It is a therapeutic device designed to treat hearing loss, not a diagnostic device that analyzes biological samples.
- Intended Use: The intended use clearly states it is for the "treatment of patients who have conductive or mixed hearing loss" and "Single-Sided Deafness." This is a therapeutic indication, not a diagnostic one.
- Device Description: The description details how the device works by converting acoustic signals to mechanical action and transmitting sound through bone, bypassing damaged parts of the ear. This process does not involve analyzing biological samples.
Therefore, the Cochlear™ Baha® 5 SuperPower Sound Processor falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cochlear™ Baha® 5 SuperPower Sound Processor is intended for the following patients and indications for use:
- Patients aged 5 and older o
- Patients who have a conductive or mixed hearing loss and can still benefit from sound ● amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 65 dB HL for use with the Baha 5 SuperPower Sound Processor.
- Bilateral fitting is intended for patients who meet the above criterion in both ears, with o bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measure at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
- Patients who suffer from unilateral sensorineural deafness in one was with normal ● hearing in the other ear (i.e. Single-sided deadness: SSD™). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measure at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
- Baha for SSD is also indicated for any patient who is indicated for an air-conduction ● contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
The Cochlear™ Baha® 5 SuperPower Sound Processor is intended for treatment of patients who have conductive or mixed hearing loss as a result of certain medical conditions such as bilateral atresia and chronic supportive otitis media, and for those who have Single-Sided Deafness (SSD) caused by a congenital condition, surgery, trauma, or disease.
The Cochlear™ Baha® 5 SuperPower Sound Processor has the following indications for use:
• Patients of any age for use with the Baha Softband or headband. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
· Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 65 dB HL.
· Bilateral fitting is intended for patients who meet the criterion in both ears, with bilateral symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
· Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-Sided Deafness; SSD). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
• Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
Product codes (comma separated list FDA assigned to the subject device)
LXB
Device Description
The Cochlear™ Baha® 5 SuperPower Sound Processor functions by combining the external sound processor with an abutment and a small titanium implant placed that is placed in the skull behind the ear through a simple surgical procedure. The sound processor transmits acoustic signals into electrical signals when then causes mechanical action in the transducer to transmit sound transcranially to the functioning auditory system.
The Baha system combines an external sound processor, in this application the Cochlear™ Baha® 5 SuperPower Sound Processor, with an abutment and small titanium implant placed into the bone through a simple surgical procedure. The implant subsequently forms an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear, bypassing a damaged outer or middle ear. The Baha system provides an alternate pathway for patients who may not benefit from wearing an air-conduction hearing aid. The changes introduced in this 510(k) are specific to the sound processor, not the abutment/implant or magnet. These changes culminate as the next generation Baha sound processor that provides recipients with moderately severe hearing loss (up to 65dB SNHL) access to sound. The Cochlear™ Baha® 5 SuperPower Sound Processor includes a decoupling of the microphone/processor and the actuator unit to allow various wearing options. The wearing options allow the recipient to achieve maximum gain while minimizing the likelihood of feedback. The design has been modified to incorporate a new rechargeable lithium-ion battery pack which provides the power needed for recipients with up to 65dB SNHL measured by pure tone average bone-conduction hearing thresholds at 0.5, 1, 2, and 3 kHz. This change does not modify the intended functionality or fundamental operating principles of the implant/abutment system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull behind the ear, inner ear, outer or middle ear
Indicated Patient Age Range
Patients aged 5 and older; Patients of any age for use with the Baha Softband or headband.
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)
Performance testing was conducted to compare the Cochlear™ Baha® 5 SuperPower Sound Processor with the predicate implant / abutment systems. Substantial equivalence to the predicate device was accomplished through environmental testing, reliability and durability testing, electrical interface testing, and functional and performance testing. The results demonstrated the Cochlear™ Baha® 5 SuperPower Sound Processor is functionally equivalent to the predicate devices.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cochlear Americas Mr. Tristan Manus Regulatory Affairs Specialist 13059 E. Peakview Ave. Centennial. CO 80111
Re: K153245
Trade/Device Name: Baha 5 Super Power Sound Processor Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: January 29, 2016 Received: February 1, 2016
Dear Mr. Manus:
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.
1
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 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 contact the Division of Industry and Consumer Education 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. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Alexander
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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4. Indications for Use Statement
510(k) Number (if known): K153245
Device Name: Cochlear™ Baha® 5 SuperPower Sound Processor
Indications for Use:
The Cochlear™ Baha® 5 SuperPower Sound Processor is intended for the following patients and indications for use:
- Patients aged 5 and older o
- Patients who have a conductive or mixed hearing loss and can still benefit from sound ● amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 65 dB HL for use with the Baha 5 SuperPower Sound Processor.
- Bilateral fitting is intended for patients who meet the above criterion in both ears, with o bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measure at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
- Patients who suffer from unilateral sensorineural deafness in one was with normal ● hearing in the other ear (i.e. Single-sided deadness: SSD™). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measure at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
- Baha for SSD is also indicated for any patient who is indicated for an air-conduction ● contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE FO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
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K153245
510(K) Summary
A. Submitter Information Submitted by:
On behalf of the manufacturer
Contact:
B. Date Prepared
C. Device Class D. Device Name
Trade/Proprietary Name:
Common/Usual Name: Classification Name:
Classification Panel: Product Code: 510(k):
E. Predicate Device
(Primary) Trade/Proprietary Name: Common/Usual Name: Classification Name:
Classification Panel Product Code: 510(k):
(Secondarv) Trade/Proprietary Name: Common/Usual Name: Classification Name:
Classification Panel:
Cochlear Americas 13059 East Peakview Ave. Centennial, CO 80111
Cochlear Bone Anchored Solutions AB Konstruktionsvagen 14 SE-435 33 Molnlycke Sweden (Establishment Number 9616024)
Tristan Manus Regulatory Affairs Specialist II Cochlear Americas tmanus@cochlear.com (303) 264-2149 (o) (303) 524-6825 (f)
November 6th 2015
II
Cochlear™ Baha® 5 SuperPower Sound Processor Hearing Aid (Bone Conduction) Hearing Aid, Bone Conduction, Implanted 21 CFR 874.3300, Class II Ear, Nose, and Throat LXB K153245
Cordelle II Sound Processor Auditory Osseointegrated Implant Hearing Aid, Bone Conduction, Implanted 21 CFR 874.3300, Class II Ear, Nose, and Throat LXB K150751
Baha 5 Sound Processor Auditory Osseointegrated Implant Hearing Aid, Bone Conduction, Implanted 21 CFR 874.3300, Class II Ear, Nose, and Throat
4
Product Code: 510(k):
LXB K142907
F. Purpose of Submission
This submission is adding the Cochlear™ Baha® 5 SuperPower Sound Processor to the series of processors offered by Cochlear Bone Anchored Solutions (BAS). The Cochlear™ Baha® 5 SuperPower Sound Processor functions by combining the external sound processor with an abutment and a small titanium implant placed that is placed in the skull behind the ear through a simple surgical procedure. The sound processor transmits acoustic signals into electrical signals when then causes mechanical action in the transducer to transmit sound transcranially to the functioning auditory system.
G. Device Description
The technology base for the Baha implant was originally derived from the 1952 discovery by Dr. Per-Ingvar Branemark that titanium was biocompatible with bone, leading to the term "osseointegration"". The Branemark System, as it would later be known, formed the basis for the rapid development and widespread implementation of root form endosseous dental implants, now safely and effectively used by many hundreds of thousands of people worldwide. Root form dental implants share many characteristics with the Baha implant component including material, conformation, and surgical implantation procedures. Unlike hearing aids, the Baha hearing system utilizes a natural bone conduction pathway to send sound directly to a cochlea with residual functionality. The Baha system combines an external sound processor, in this application the Cochlear™ Baha® 5 SuperPower Sound Processor, with an abutment and small titanium implant placed into the bone through a simple surgical procedure. The implant subsequently forms an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear, bypassing a damaged outer or middle ear. The Baha system provides an alternate pathway for patients who may not benefit from wearing an air-conduction hearing aid. The changes introduced in this 510(k) are specific to the sound processor, not the abutment/implant or magnet. These changes culminate as the next generation Baha sound processor that provides recipients with moderately severe hearing loss (up to 65dB SNHL) access to sound. The Cochlear™ Baha® 5 SuperPower Sound Processor includes a decoupling of the microphone/processor and the actuator unit to allow various wearing options. The wearing options allow the recipient to achieve maximum gain while minimizing the likelihood of feedback. The design has been modified to incorporate a new rechargeable lithium-ion battery pack which provides the power needed for recipients with up to 65dB SNHL measured by pure tone average bone-conduction hearing thresholds at 0.5, 1, 2, and 3 kHz. This change does not modify the intended functionality or fundamental operating principles of the implant/abutment system.
H. Intended Use
The Cochlear™ Baha® 5 SuperPower Sound Processor is intended for treatment of patients who have conductive or mixed hearing loss as a result of certain medical conditions such as bilateral atresia and chronic supportive otitis media, and for those who have Single-Sided Deafness (SSD) caused by a congenital condition, surgery, trauma, or disease.
I. Indications for Use
The Cochlear™ Baha® 5 SuperPower Sound Processor has the following indications for use:
• Patients of any age for use with the Baha Softband or headband. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
5
· Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 65 dB HL.
· Bilateral fitting is intended for patients who meet the criterion in both ears, with bilateral symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
· Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-Sided Deafness; SSD). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
• Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
J. Technological Characteristics
The Cochlear™ Baha® 5 SuperPower Sound Processor has the same intended use, the same mechanical design, the same functional characteristics, the same fundamental operating principles, and is made of biocompatible materials as the predicate devices.
K. Materials
The Cochlear™ Baha® 5 SuperPower Sound Processor is made of medical grade plastics and metals that have been shown to be biocompatible and safe for human use.
L. Performance Data
Performance testing was conducted to compare the Cochlear™ Baha® 5 SuperPower Sound Processor with the predicate implant / abutment systems. Substantial equivalence to the predicate device was accomplished through environmental testing, reliability and durability testing, electrical interface testing, and functional and performance testing. The results demonstrated the Cochlear™ Baha® 5 SuperPower Sound Processor is functionally equivalent to the predicate devices.
M. Conclusion
Based on the indications for use, technological characteristics, and substantial equivalence comparison to the predicate device, the Cochlear™ Baha® 5 SuperPower Sound Processor has been shown to be safe and effective for its intended use.