(79 days)
Starkey SM PC, Starkey SM Vega, Bosch Star 22
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No
The device description is very basic, focusing on linear amplification and physical controls, with no mention of adaptive processing, algorithms, or any terms related to AI/ML.
No.
The device is a hearing instrument for individuals with hearing loss, which is a compensatory device rather than a therapeutic one aiming to cure or treat a disease.
No.
The device's description and intended use clearly state it is a "hearing instrument" designed to assist individuals with hearing loss by amplifying sound, not to diagnose medical conditions or provide information for medical diagnosis.
No
The device description explicitly states it is a "linear hearing device" with "electronics" contained in a "custom acrylic plastic case" and a "volume wheel," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for individuals with hearing loss, which is a physiological condition, not the diagnosis of a disease or condition through the examination of specimens derived from the human body.
- Device Description: The device is a hearing instrument, which is a medical device used to amplify sound for individuals with hearing impairment. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
Therefore, the Ototech International Model Alpha Behind-The-Ear Hearing Instrument is a medical device, but it falls under the category of a hearing aid, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ototech International Model Alpha Behind-The-Ear Hearing Instrument is intended for use by individuals with Moderate or Mild to Severe hearing loss.
Product codes
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Device Description
The Model Alpha is a linear hearing device. The electronics for this hearing instrument are contained in a custom acrylic plastic case. The device has one user control - the volume wheel, and no potentiometers. The device does not require any special fitting systems.
The acoustical output of the Ototech Model Alpha is a maximum SSPL90 of 122 dB SPL (ANSI S3.22, 1987). The reference test gain is 43 dB SPL.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Starkey SM PC, Starkey SM Vega, Bosch Star 22
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.
0
510(k) SUMMARY
OTOTECH INTERNATIONAL MODEL ALPHA BEHIND-THE-EAR AUG 28 1998 HEARING INSTRUMENTS.
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
David A. Hough Ototech International Incorporated 3400 N.W. 56 Oklahoma City, Oklahoma 73112
Contact Person: Same as above
Date Prepared: 5/20/96
Name of device and Name/Address of Sponsor
Model Alpha Behind-The-Ear Hearing Instruments
Ototech International Inc. 3400 N.W. 56 Oklahoma City, Oklahoma 73112
Classification Name
The Model Alpha Behind-The-Ear Hearing Instrument is among those devices commonly referred to as air conduction hearing aids. The devices have been classified by the Ear, Nose and Throat Classification Panel as Class I devices set forth in 21 CFR 874.3300.
Predicate Devices
Starkey SM PC Starkey SM Vega Bosch Star 22
1
Proposed Labels, Labeling and Advertisements Sufficient to Describe the Device, its Intended Use and the Directions for its Use.
Included in this submission are the proposed labeling for the Ototech International Model Alpha Behind-The-Ear Hearing Instrument. This includes the User Instruction Booklet (Appendix A), Label Specifications (Appendix B), Product Specification/Fitting Information (Appendix C), and Substantially Equivalent Devices (Appendix D).
Intended Use
The Ototech International Model Alpha Behind-The-Ear Hearing Instrument is intended for use by individuals with Moderate or Mild to Severe hearing loss.
Product Description
The Model Alpha is a linear hearing device. The electronics for this hearing instrument are contained in a custom acrylic plastic case. The device has one user control - the volume wheel, and no potentiometers. The device does not require any special fitting systems.
The acoustical output of the Ototech Model Alpha is a maximum SSPL90 of 122 dB SPL (ANSI S3.22, 1987). The reference test gain is 43 dB SPL.
Technological Characteristics and Substantial Equivalence
Ototech Alpha Behind-the-Ear Hearing Instrument Data according to ANSI S3.22-1987 1. Electrical and Acoustical Data
| SSPL90 maximum output | 122 dBSPL |
|---|---|
| HF average SSPL90 | 121 dBSPL |
| HF average full-on gain | 50 dBSPL |
| Reference test gain | 43 dBSPL |
| Equivalent input noise | 25 dBSPL |
| Frequency range | 200-5800 Hz |
| T.H.D. at 500 Hz | 5 % |
| T.H.D. at 800 Hz | 5 % |
| T.H.D. at 1600 Hz | 3 % |
| Battery Size | 675 |
| Battery Type | Zinc-air |
| Battery current drain | .9 mA |
| Typical battery life | 600hrs |
2
The three predicate devices listed above are also linear devices having similar maximum output ranging from 118 to 127dB SPL, and similar gain ranging from 33 to 45dB SPL. The Starkey SM Vega has no potentiometers. The Bosch Star 22 has a tone potentiometer. The Starkey SM PC has one output and one tone potentiometer.
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