(116 days)
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No
The summary describes a bone conduction hearing system that uses a prescriptive formula and software adjustments for individual patient hearing loss, which are standard features in hearing aids and do not indicate the use of AI/ML. There is no mention of AI, ML, or related concepts like deep learning or neural networks.
Yes
The device is a sound processor used for patients with hearing loss, which aims to improve their hearing and quality of life by amplifying sound through bone conduction. This directly addresses a medical condition and provides a therapeutic benefit.
No
The device is described as a sound processor for hearing amplification in patients with hearing loss, and its main function is to transduce sound vibrations via bone conduction. There is no mention of it being used for diagnostic purposes, such as identifying or characterizing a medical condition.
No
The device description explicitly states that the Otomag Alpha 1 Sound Processor is a physical sound processor that attaches magnetically to a headband or softband and transduces vibration through direct contact with the patient's skin and bone. This indicates a hardware component is central to the device's function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Otomag Alpha 1 Sound Processor is a hearing aid system that works by transmitting sound vibrations through bone conduction to improve hearing. It does not analyze biological samples.
- Intended Use: The intended use clearly describes its function in addressing hearing loss, not in diagnosing a condition through sample analysis.
- Device Description: The description focuses on the mechanical and acoustic principles of the device, not on laboratory testing.
Therefore, the Otomag Alpha 1 Sound Processor falls under the category of a medical device, specifically a hearing aid, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Otomag Alpha 1 Sound Processor is intended for use with the Otomag Headband or Otomag Softband (no age limitations) for the following patients and indications:
- Patients with conductive or mixed hearing losses, who can still benefit from amplification of 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).
- 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 10dB 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, 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 be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
The Otomag Alpha 1 (S) Sound Processor is intended to the Otomag Headband or Softband.
Product codes (comma separated list FDA assigned to the subject device)
LXB
Device Description
The Otomag Bone Conduction Hearing System is a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations.
The Otomag System called the Alpha 1 (S), the Otomag Sound Processor is attached magnetically to a headband or softband. The headband or softband holds the sound processor against the head and vibration is transduced through direct contact with the patient's skin and the bone below.
The Otomag System is designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing loss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments available to the audiologist in the software allow for programming the Otomag System for individual patient hearing loss.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
no age limitations
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Summary of Non-Clinical Testing: The non-clinical testing presented in this submission demonstrates the Otomag System's performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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 shows handwritten text and printed text. The handwritten text at the top left reads "K100193 page 1 of 2". The printed text below reads "Sophono - 510(k) - The Otomag System - Section 5. 510(k) Summary".
5. 510(K) SUMMARY
Applicant Name and Address:
Sophono, Inc. 903 Brooklawn Dr. Boulder, Colorado 80303
MAY 1 8 2010
| Establishment Registration Number: | None at this time |
|---|---|
| Device Name: | Otomag Bone Conduction Hearing System |
| Classification: | 874.3300 |
| Classification Name: | Bone Conduction Hearing Aid |
| Product Code: | LXB |
Date Prepared: January 20, 2010
510(k) Contact Person and Phone Number:
- Company: Mary Armstrong 555 Zang Street, Suite 100 Lakewood, CO 80228
Phone 303-223-4336 303-832-6700 Fax
Name and Address of Manufacturing Site:
- Company: Otomag GmbH Alte Dorfstrasse 67 D-32289 Rodinghausen Germany
Manufacturing Site Contact Person and Phone Number:
Contact Name: Andreas Sentker
| Phone: | +49 05746/8504 |
|---|---|
| Fax: | +49 05746/8578 |
Predicate Devices:
The Otomag Bone Conduction Hearing System is claimed to be substantially equivalent in material, design and function to the bone conduction versions of the following legally marketed predicate devices that utilize a headband and / or softband:
- Oticon Medical Ponto Pro Bone Anchored Sound Processor K090996 .
- Cochlear BAS Baha BP100 Sound Processor K090720 .
General Description:
The Otomag Bone Conduction Hearing System is a family of sound processors and accessories that operate on the principle of bone conduction of sound vibrations.
The Otomag System called the Alpha 1 (S), the Otomag Sound Processor is attached magnetically to a headband or softband. The headband or softband holds the sound processor against the head and vibration is transduced through direct contact with the patient's skin and the bone below.
The Otomag System is designed for use for those patients with conductive hearing loss, those patients who have sensorineural hearing loss up to 45 dB in combination with their conductive loss, and single sided deafness as defined in the indications for use. The prescriptive formula and adjustments available to the audiologist in the software allow for programming the Otomag System for individual patient hearing loss.
1
K100193 page 2 of 2
Sophono - 510(k) - The Otomag System - Section 5. 510(k) Summary
Indications for Use:
The Otomag Alpha 1 Sound Processor is intended for use with the Otomag Headband or Otomag Softband (no age limitations) for the following patients and indications:
- Patients with conductive or mixed hearing losses, who can still benefit from amplification . of 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).
- 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 10dB 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, 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 be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
The Otomag Alpha 1 (S) Sound Processor is intended to the Otomag Headband or Softband.
Contraindications:
The Otomag Alpha 1 (S) Sound Processor connected to the Otomag Headband or Softband is contraindicated as follows;
Any factor that would cause a clinician to refer the patient for medical assessment will temporarily, or in some cases permanently, halt the process of hearing aid fitting. These factors include:
- a hearing loss of sudden onset; .
- a rapidly progressing hearing loss; ●
- pain in either ear; �
- . tinnitus of sudden recent onset, or unilateral tinnitus;
- unilateral or markedly asymmetrical hearing loss of unknown origin; .
- vertigo (e.q. dizziness) .
Summary of Technical Characteristics
The technical specifications of the Otomag Alpha 1 Sound Processor are substantially equivalent to the technical specifications of the predicate devices discussed in this 510(k).
Summary of Non-Clinical Testing
The non-clinical testing presented in this submission demonstrates the Otomag System's performance is substantially equivalent to the predicate devices.
Conclusion
The Otomag System is considered to be substantially equivalent in design, material and function to the bone conduction versions of the previously 510(k) (K090996 & K090720) cleared predicate devices that utilize a headband and / or softband, without raising new issues of safety and / or effectiveness.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Sophono, Inc. c/o Mary Armstrong Director of Regulatory Affairs Reglera LLC 555 Zang Street, Suite 100 Lakewood, CO 80228
MAY 1 8 2010
Re: K100193
Trade/Device Name: Otomag Bone Conduction Hearing System Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: April 12, 2010 Received: April 14, 2010
Dear Ms. Armstrong:
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. Iisting 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 mav 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
3
Page 2 -- Mary Armstrong
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.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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ruli. Jom, m.
Melvin R. Fuldman, M.D.
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
Enclosure
4
Indications for Use
510(k) Number: K100193
Device Name: Otomag Bone Conduction Hearing System
Indications for Use:
The Otomag Alpha 1 Sound Processor is intended for use with the Otomag Headband or Otomag Softband (no age limitations) for the following patients and indications:
- . Patients with conductive or mixed hearing losses, who can still benefit from amplification of 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).
- . 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 10dB 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, 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 be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
The Otomag Alpha 1 (S) Sound Processor is intended to the Otomag Headband or Softband.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (O | |
|---|---|
| ----------------------------------------------------- | -- |
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off), Page
Division of Ophthalmie, Neurological and Ear,
Nose and Throat Devices
10(k) Number K100193