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510(k) Data Aggregation
(239 days)
Moderate to severe conductive hearing losses. Particularly useful for conductive losses compounded by congenital or secondary obstruction of auditory air conduction mechanisms
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Second Ear® Bone Conduction Hearing Aid (K953872):
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state formal acceptance criteria. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" are implicitly met if the device's characteristics and performance are comparable to the predicates, indicating it's as safe and effective.
The provided "FEATURE COMPARISON TABLE" serves as the primary evidence for this comparison.
| Feature | Acceptance Criteria (Implied by Predicates) | Reported Device Performance (Second Ear®) | Meets Criteria? (Based on document claims) |
|---|---|---|---|
| Materials | Medical grade plastic | Medical grade plastic | Yes |
| Indications for Use | Primarily: Moderate to severe conductive hearing losses; particularly useful for conductive losses compounded by congenital or secondary obstruction of auditory air conduction mechanisms | Moderate to severe conductive hearing losses; particularly useful for conductive losses compounded by congenital or secondary obstruction of auditory air conduction mechanisms | Yes |
| Power Requirement | Battery-powered; typically NiCad, R675, R6-AA Nickel Metal & Alkaline Battery (as seen in predicates) | 4.8 VDC Nickel-Metal-Hydride Battery (rechargeable, 600mA-hrs capacity) - Note: Different battery technology but comparable functionality and improved longevity is implicitly presented as an advantage | Yes (with implied equivalency of function) |
| Frequency Response | Range covering 100 Hz to 6.6 KHz (depending on predicate unit), or 200 Hz to 4 KHz (as seen in Radioear) | 150 Hz to 8 KHz (without filter); 300 Hz to 3 KHz (with voice filter) | Yes (comparable or extended range) |
| Max. Gain | Range from 60-86 dB (depending on Unitron model); Not Stated for Radioear/Starkey | 57 dB | Yes (within a comparable functional range) |
| Device Class | Class II | Class II | Yes |
| Classification Code | 77LXB | 77LXB | Yes |
| Sound Conduction Mechanism | Transmit audio vibrations through the bones of the skull (bone conduction) | Sound transmitted directly through the bones of the skull to the cochlea | Yes |
| Overall S/N Ratio | Not explicitly stated as a comparative metric for predicates, but generally, acceptable levels for hearing aids. | 40dB | Not explicitly compared, but stated |
| Battery Life (Normal Use) | Typically relies on disposable batteries; comparative rechargeable battery life not specified for predicates. | 24 to 48 hours of operation from fully charged batteries (with rechargeable pack) | Not directly comparable, but stated |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" or a clinical study with real patient data used to demonstrate performance. The entire basis for establishing equivalence is through a comparison of technical specifications and features with already marketed predicate devices.
Therefore:
- Sample size for the test set: Not applicable (no test set described).
- Data provenance: Not applicable (no patient data used for comparison/testing). The data is derived from the technical specifications of the Second Ear® and its identified predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical test set or study is described, there's no mention of experts establishing ground truth in this context. The "ground truth" for substantial equivalence is effectively the established performance and safety profile of the predicate devices as determined by their prior FDA clearances.
4. Adjudication Method for the Test Set
Not applicable, as no test set or clinical study requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this 510(k) summary. This type of study would involve human readers (e.g., audiologists, patients) assessing performance with and without the device, and potentially comparing it to other devices. This 510(k) relies purely on technical specifications.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a hardware hearing aid; it does not involve an "algorithm only" component. Performance is inherent to the physical device. The document does not describe any standalone performance testing in the sense of a formal clinical trial or laboratory study with performance metrics beyond the technical specifications listed. The "standalone performance" is implicitly established by the technical specifications presented in the comparison table.
7. The Type of Ground Truth Used
The "ground truth" used for this 510(k) submission is the established performance and safety profiles of the legally marketed predicate devices. The new device's specifications are compared against these known, cleared devices to argue for substantial equivalence. There is no pathology, expert consensus, or outcomes data presented for the Second Ear® itself in this document.
8. The Sample Size for the Training Set
Not applicable. The device is a hardware hearing aid; there is no machine learning "training set" involved.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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