(239 days)
Not Found
No
The description focuses on hardware components, bone conduction technology, and basic audio processing features like tone control and a voice filter. There is no mention of adaptive algorithms, learning capabilities, or data processing that would indicate AI/ML.
Yes
The device is a bone conduction-type hearing aid designed to address conductive hearing losses by transmitting sound directly to the cochlea, which is a therapeutic function.
No
The device description indicates that the EC-1000 Second Ear is a bone conduction-type hearing aid designed to transmit sound, not to diagnose a condition.
No
The device description clearly outlines hardware components including a transducer unit, an audio processor/driver module, a wire cable, and a battery pack. It is a physical device that transmits sound through bone conduction.
Based on the provided information, the EC-1000 Second Ear is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EC-1000 Function: The EC-1000 Second Ear is a hearing aid that works by transmitting sound through bone conduction to the cochlea. It directly interacts with the user's body to improve hearing, rather than analyzing a biological sample.
- Intended Use: The intended use is to address moderate to severe conductive hearing losses, which is a therapeutic or assistive function, not a diagnostic one based on analyzing a sample.
- Device Description: The description details a bone conduction hearing aid with components like a transducer, audio processor, and battery. None of these components are designed for analyzing biological specimens.
Therefore, the EC-1000 Second Ear falls under the category of a medical device, specifically a hearing aid, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Moderate to severe conductive hearing losses. Particularly useful for conductive losses compounded by congenital or secondary obstruction of auditory air conduction mechanisms
Product codes (comma separated list FDA assigned to the subject device)
77LXB
Device Description
The EC-1000 Second Ear is a bone conduction-type hearing aid. Unlike conventional products which depend upon acoustic coupling through air, the EC-1000 Second Ear is based on bone conduction technology. Sound is transmitted directly through the bones of the skull to the cochlea, bypassing the outer and middle ear.
The EC-1000 Second Ear offers an innovative tone control system, providing flexible audio control adjustments. Also, features such as a voice filter which when selected, reduces additional exterior sound. As an added feature an auxiliary input jack allows the user to connect Search Eas ® directly to TV, CD players, portable radios, tape players or even telephones.
State of the art nickel-metal-hydride rechargeable battery technology is used for maximum battery life while minimizing size and weight.
Transducer
The EC-1000 Second Ear consists of a transducer unit, a shirt pocket sized audio processor/driver module and a wire cable for connecting the transducer with the audio processor/driver. The transducer is a convenient sized unit that is held against the head and is driven electrically to transmit audio vibrations to the underlying bones of the skull. It is a low-impedance device, similar to a loudspeaker.
Audio Processor/Driver
The audio processor/driver module connects the transducer through the wire cable and usually would be carried in the users pocket. The wire cable connecting the audio processor/driver and the transducer can be placed comfortably at sensitive location such as behindear.
The audio processor/driver module is completely self-contained and is battery powered. It also has a built-in microphone for picking up sound. A rechargeable battery pack is the power source.
Battery Pack
The battery pack can be charged in place in the unit or snapped out for easy exchanging. By purchasing a spare battery pack, the user can be using one battery while charging the other, guaranteeing uninterrupted use of the EC-1000. The user should be able to obtain 24 to 48 hours of operation in normal use from fully charged batteries. Volume setting and environmental conditions affect battery life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
bones of the skull, outer and middle ear
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
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): 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.
Not Found
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.
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
APR 1 2 1996
Section 510(k) Premarket Notification Summary of Safety and Effectiveness Information
U
Safe Medical Devices Act of 1990, 21 CFR 807.92 Requlatory Authority:
- Second Ear® Bone Conduction Hearing Aid 1. Device Trade Name:
2. Common / Classification Name:
Common Name: Bone Conduction Hearing Aid
Classification Name: Hearing Aid
3. Applicant / Sponsor Name / Address:
WORDCOMP INTERNATIONAL COMMUNICATION GROUP 4700 Von Karman, Suite 115 Newport Beach, California 92660 (714) 752-6677 - (714) 752-6769 Fax
4. Contact Person:
Mr. Masanori Tada WORDCOMP INTERNATIONAL COMMUNICATION GROUP 4700 Von Karman, Suite 115 Newport Beach, California 92660 (714) 752-6677 - (714) 752-6769 Fax
5. Establishment Registration Number:
9021402 Number:
6. Classification:
§ 874.3300 Hearing Aid. (a) Identification. A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device includes the airconduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer (874.3320), master hearing aid (874.3330), and tinnitus masker (874.3400). (b) Classification. (1) Class I for the air-conduction hearing aid. (2) Class II for the bone-conduction hearing aid.
| Device Class: | Class II |
|---|---|
| Classification Panel: | Ear, Nose & Throat Devices Panel |
| Classification Code: | 77LXB |
1
7. Substantially Equivalent Device(s):
- Starkey Model BC1 Bone Conduction CROS Hearing Aid 1.
- Unitron® Bone Conduction Hearing Aid 2.
- Radioear B70 Series Audio Transducers 3.
8. Device Description:
The EC-1000 Second Ear ' is a bone conduction-type hearing aid. Unlike conventional products which depend upon acoustic coupling through air, the EC-1000 Second Earl is based on bone conduction technology. Sound is transmitted directly through the bones of the skull to the cochlea, bypassing the outer and middle ear.
The EC-1000 Second Ear offers an innovative tone control system, providing flexible audio control adjustments. Also, features such as a voice filter which when selected, reduces additional exterior sound. As an added feature an auxiliary input jack allows the user to connect Search Eas ® directly to TV, CD players, portable radios, tape players or even telephones.
State of the art nickel-metal-hydride rechargeable battery technology is used for maximum battery life while minimizing size and weight.
Transducer
The EC-1000 Second Ear consists of a transducer unit, a shirt pocket sized audio processor/driver module and a wire cable for connecting the transducer with the audio processor/driver. The transducer is a convenient sized unit that is held against the head and is driven electrically to transmit audio vibrations to the underlying bones of the skull. It is a lowimpedance device, similar to a loudspeaker.
Audio Processor/Driver
The audio processor/driver module connects the transducer through the wire cable and usually would be carried in the users pocket. The wire cable connecting the audio processor/driver and the transducer can be placed comfortably at sensitive location such as behindear.
The audio processor/driver module is completely self-contained and is battery powered. It also has a built-in microphone for picking up sound. A rechargeable battery pack is the power source.
Battery Pack
The battery pack can be charged in place in the unit or snapped out for easy exchanging. By purchasing a spare battery pack, the user can be using one battery while charging the other, guaranteeing uninterrupted use of the EC-1000. The user should be able to obtain 24 to 48 hours of operation in normal use from fully charged batteries. Volume setting and environmental conditions affect battery life.
2
Packaging:
Standard packaging is used in the production of this device. Packaging quality is sufficient to protect the device from damage during transportation and storage. When not in use, the device should be stored in the same package as when it was supplied.
Equivalence:
The Same East Bone Conduction Hearing Aid is equivalent to the Starkey Labs, the Unitron brand bone conduction hearing aids and the Radioear Audio Transducer. The referenced units provide amplified auditory information via bone conduction as does the Same . All units are intended for use by persons with moderate to severe conductive hearing losses compounded by congenital or secondary obstruction of auditory air conduction mechanisms.
The frequency response of the Seam East Bone Conduction Hearing Aid without the voice filter is 150 Hz to 8 KHz. When the voice filter is engaged, response is 300 Hz to 3 KHz. The frequency response of the Unitron® brand bone conduction hearing aids is between 100 Hz and 6.6 KHz depending upon the unit selected. The Samme and is also equipped with treble and bass controls.
Power requirements for the Same Bone Conduction Hearing Aid are supplied by a Nickel-Metal-Hydride battery. The Same Earl Bone Conduction Hearing Aid is provided with a 12 V, 750mA AC adapter and battery charger while the competitive brands typically utilize disposable batteries. Fully charged battery capacity is 600mA-hrs for the Second East and is approximately the same for the competitive bone conduction hearing aids.
The sound conduction transducers of the Sand and the comparison units are placed against the users skin behind the ear or other bony location of the skull with the aid of a strap or headband. Maximum voltage gain for the Sund Early Bone Conduction Hearing Aid is 57dB. Overall S/N ratio for the Second Ear 10 is 40dB.
Conclusion:
A review of the provided performance specifications for the Sease and the listed comparison devices shows that all three devices are substantially the same in terms of indications for use, function, form, design, materials and performance. The feature comparison table below summarizes this information.
3
FEATURE COMPARISON TABLE
| FEATURE | Second Ear ® | Unitron | Radioear | Starkey Labs. | S. E.? |
|---|---|---|---|---|---|
| Materials: | Medical grade plastic | Same | Same | Same | Yes |
| Indications for Use: | Moderate to severe | ||||
| conductive hearing | |||||
| losses. | |||||
| Particularly useful for | |||||
| conductive losses | |||||
| compounded by | |||||
| congenital or | |||||
| secondary obstruction | |||||
| of auditory air | |||||
| conduction | |||||
| mechanisms | Same | Same | Same | Yes | |
| Power Requirement: | 4.8 VDC Nickel-Metal- | ||||
| Hydride Battery | R675 & R6-AA | ||||
| Nickel Metal & | |||||
| Alkaline Battery | NiCad, R675 & | ||||
| R6-AA Nickel | |||||
| Metal & Alkaline | |||||
| Battery | NiCad. | Yes | |||
| Frequency Response | 150Hz to 8 KHz | ||||
| 300Hz to 3 Khz w/filter | 100 Hz to 5.5 | ||||
| KHz | 200Hz to 4KHz | Not Stated | Yes | ||
| Max. Gain | 57 dB | 60-86 dB | |||
| depending on | |||||
| model | Not Stated | Not Stated | Yes | ||
| Device Class | II | II | II | II | Yes |
| Manufacturer: | WORDCOMP INTERNAT. | Unitron | Radioear | Starkey Labs, Inc. | Yes |
| Classification Code: | 77LXB | Same | Same | Same | Yes |
| K-Number | Pending | K884288 | Unknown | K923784 | NA |