(29 days)
No
The document describes technological improvements in sound processing (multichannel, non-linear programmability, automatic directionality, background noise management, active feedback cancellation, position compensation) and digital programmability, but does not mention AI or ML. These features are typical of advanced digital signal processing in hearing aids and do not inherently require AI/ML.
Yes
The device is indicated for patients with hearing loss to amplify sound and improve hearing, which are therapeutic functions.
No
The device is a sound processor designed for amplification and sound delivery to assist individuals with hearing loss, not to diagnose a condition.
No
The device description clearly states it is a "sound processor" and describes physical components like an external headband, Softband, abutment, and titanium implant. While it mentions "Baha Fitting Software," the core device is a hardware-based hearing system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Cochlear Baha® BP110 Power sound processor is a device designed to amplify and transmit sound to the inner ear, either through bone conduction via a Softband/headband or an osseointegrated implant. Its purpose is to address hearing loss.
- Lack of Specimen Analysis: The description clearly outlines how the device works with the patient's auditory system and skull bone. There is no mention of collecting or analyzing any biological specimens.
Therefore, the device falls under the category of a hearing aid or auditory prosthesis, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cochlear Baha® BP110 Power 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 55 dB HL.
- Bilateral fitting is intended for patients who meet the criterion in both ears, with 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 (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
LXB
Device Description
The subject of this Special 510(k): Device Modification is a modification to the Cochlear Baha® Intenso sound processor, which was cleared under 510(k) K081606 for unilateral or bilateral use with conductive and mixed hearing losses (as a result of congenital malformations such as atresia, or certain medical conditions such as chronic suppurative otitis media), and for cases of single-sided sensorineural deafness (SSD, caused by a congenital condition, surgery, trauma or disease). The Baha system has been marketed for more than 30 years throughout the world, and there are now more than 77,000 users of a Baha system globally.
Baha sound processors can be used with either the external Baha headband or Softband, or, for children aged 5 or older, with the Baha auditory osseointegrated implants. The external Baha headband or Softband system works via conventional transcutaneous bone conduction amplification. The Baha implant system works by combining the external sound processor with an abutment and a small titanium implant placed in the skull behind the ear in a simple surgical procedure. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the surrounding bone, allowing high-quality amplified and processed sound from the Baha sound processor to be conducted via the skull bone directly to a cochlea with residual functionality. For either form of transmission, the processed sound either bypasses a conductive block in those patients with conductive or mixed hearing loss, or transfers sound through the skull to the opposite-ear normal cochlea for patients with SSD.
The modified sound processor, the Baha BP110 Power is an upgrade to the currently marketed Baha Intenso sound processor, which it will replace on the U.S. market. The BP110 Power sound processor will provide a more modern device with technological innovations compared to the predicate Intenso. As the modified device utilizes the same fundamental scientific principles, and the same intended use and indications for use as the current legally marketed device it will replace, and merely represents improvements in features and the sound processing of the amplified sound that are the same as those used in another Cochlear Baha sound processor that has already been cleared for marketing for a less hearing-impaired population (the model BP100, cleared under K090720), we believe these modifications are appropriate for the Special 510(k) process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K090720, K002913, K100360, K955713, K090702
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
KII0996
Image /page/0/Picture/1 description: The image shows the Cochlear logo. The logo consists of a stylized ear symbol on the left and the word "Cochlear" written below it. To the right of the logo, the words "Hear now. And always" are written in a handwritten-style font. The logo is black and white.
MAY 1 0 2011
Section 8 510(k) Summary
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided.
Submitted by:
Cochlear Americas 13059 East Peakview Ave. Centennial, CO 80111
On behalf of:
Cochlear Bone Anchored Solutions AB Konstruktionsvägen 14 SE-435 33 Mölnlycke Sweden
Contact Persons:
Sean Bundy Sr. Manager, Regulatory Affairs and Compliance Phone: 303-524-7139 Facsimile: 303-524-6825 SBundy@cochlear.com Email:
Carol Sammeth, Ph.D, CCC-A Sr Regulatory Specialist 303-524-6833 Phone: 303-524-6825 Facsimile: CSammeth@cochlear.com Email:
Date Submission Prepared:
March-April 2011
Device Name:
Trade or Proprietary Name: Common or Usual Name: Classification Status: Product Codes: Panel:
Cochlear Baha® BP110 Power Sound Processor Class II, 21 CFR §874.3300 LXB Ear Nose and Throat Specialty Panel
1
Image /page/1/Picture/0 description: The image shows the Cochlear logo. The logo consists of a stylized cochlea shape on the left, followed by the word "Cochlear" with a trademark symbol. To the right of the company name is the phrase "Hear now. And always" in a handwritten-style font.
Device Description:
The subject of this Special 510(k): Device Modification is a modification to the Cochlear Baha® Intenso sound processor, which was cleared under 510(k) K081606 for unilateral or bilateral use with conductive and mixed hearing losses (as a result of congenital malformations such as atresia, or certain medical conditions such as chronic suppurative otitis media), and for cases of single-sided sensorineural deafness (SSD, caused by a congenital condition, surgery, trauma or disease). The Baha system has been marketed for more than 30 years throughout the world, and there are now more than 77,000 users of a Baha system globally.
Baha sound processors can be used with either the external Baha headband or Softband, or, for children aged 5 or older, with the Baha auditory osseointegrated implants. The external Baha headband or Softband system works via conventional transcutaneous bone conduction amplification. The Baha implant system works by combining the external sound processor with an abutment and a small titanium implant placed in the skull behind the ear in a simple surgical procedure. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the surrounding bone, allowing high-quality amplified and processed sound from the Baha sound processor to be conducted via the skull bone directly to a cochlea with residual functionality. For either form of transmission, the processed sound either bypasses a conductive block in those patients with conductive or mixed hearing loss, or transfers sound through the skull to the opposite-ear normal cochlea for patients with SSD.
The modified sound processor, the Baha BP110 Power is an upgrade to the currently marketed Baha Intenso sound processor, which it will replace on the U.S. market. The BP110 Power sound processor will provide a more modern device with technological innovations compared to the predicate Intenso. As the modified device utilizes the same fundamental scientific principles, and the same intended use and indications for use as the current legally marketed device it will replace, and merely represents improvements in features and the sound processing of the amplified sound that are the same as those used in another Cochlear Baha sound processor that has already been cleared for marketing for a less hearing-impaired population (the model BP100, cleared under K090720), we believe these modifications are appropriate for the Special 510(k) process.
Intended Use:
The new Baha BP110 Power will be used as an external sound processor option (in the Cochlear Baha family of sound processors) to conduct sound energy directly to the cochlea via a Baha auditory osseointegrated implant, or via transcutaneous
2
Image /page/2/Picture/0 description: The image shows the Cochlear logo, which includes a stylized ear symbol and the word "Cochlear" in a distinct font. To the right of the logo, the phrase "Hear now. And always" is written in a cursive style. The overall design is simple and aims to convey the company's focus on hearing solutions.
transmission with a Baha headband or Softband. This is the same intended use, and for the same patient population, as the current legally marketed, unmodified Baha Intenso device (the predicate device that it will replace).
Technological Characteristics:
The modified sound processor will still be compatible with the currently marketed Softband/headband (cleared under K002913 and letters to file under this clearance), and the currently marketed auditory osseointegrated implant (BIA300 system, cleared under K100360), and will also be backward compatible with the original auditory osseointegrated implant (cleared under K955713).
The primary modifications proposed are technological improvements so that the BP110 Power will be digitally programmable, allow up to three user-selectable listening programs and measurement of direct bone conduction thresholds (through the sound processor) for greater accuracy in fitting, and provide a number of sound processing improvements and features that have already been cleared for another Baha sound processor intended for a less severely impaired population (the Baha BP100. cleared under K090720). Improvements in sound processing include multichannel, non-linear programmability, advanced automatic directionality, background noise management, active feedback cancellation, and position compensation. The BP110 Power can be fit with Baha Fitting Software (also previously cleared under K090702), which has proprietary amplification strategies for direct bone conduction delivery of amplified sound. The BP110 Power also has audible and visible indicators (LEDs and beeps) for monitoring the status of the sound processor, a Europlug for compatibility with standard accessories and mainstream FM devices, and tamper proof features for the pediatric population. These modifications will result in a device that will provide more individual flexibility and accuracy in fitting and an increased number of sound processing options and features currently found in air conduction hearing aids (Class I, Exempt).
Conclusions: C
Despite technological improvements and the upgrade to new sound processing features, the Baha BP110 Power sound processor still has substantially equivalent function and technology, and the same intended use as the predicate Baha Intenso sound processor cleared for marketing under K081606. The indication for use statement is also the same as that for the current legally marketed Baha Intenso sound processor that it will replace.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 0 2011
Cochlear Americas c/o Sean Bundy Sr. Manager Affairs and Compliance 13059 East Peakview Ave. Centennial, CO 80111
Re: K110996
Trade/Device Name: Cochlear™ Baha® BP110 Power Sound Processor Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid, Bone Conduction Regulatory Class: Class II Product Code: LXB Dated: April 8, 2011 Received: April 11, 2011
Dear Mr. Bundy:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
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.fda.gov/MedicalDevices/Safety/ReportalProblem/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 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.
Kesia Alexander
Malvina B. Eydelman, M.D.
Director
Division of Ophthalmic, Neu
and Ear, Nose and Throat
Office of Device Evaluation
Center for Devices and
Enclosure
Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation
Radiological Health
5
510(k) Number (if known): K //0996
Device Name: Cochlear Baha® BP110 Power Sound Processor
Indications for Use Statement:
The Cochlear Baha® BP110 Power 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 55 dB HL.
- Bilateral fitting is intended for patients who meet the criterion in both ears, . with 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 (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.
Prescription Use × (21 CFR 801 Subpart C) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D)
. .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off Division of Ophthalmic, Neurological and
10(k) Number K110996
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