(135 days)
Bone conduction hearing aids by BHM-Tech are wearable sound-amplifying devices intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional.
The target populations for the devices are as follows:
AN-Evo1 adults and children (≥ 12 years)
contact star evo1 adults and children (≥ 12 years)
contact mini adults and children (≥ 8 months)
apollon adults and children (≥ 12 years)
The apollon is a device where it is capable of utilizing either air or bone conduction.
AN-Evo1: Different to the more common air conduction hearing devices, with digital bone conducted hearing aids AN-Evo1 the sound is produced in a small vibrator and transmitted by direct contact to the mastoid. From here the sound is transmitted via the skull to the inner ear and transformed directly into nerve impulses. The AN-Evo1 is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different aid front-models. For mounting, extension tips and aidfronts with different mechanical dimensions (lengths of extension tips, size of aid-fronts) are available. The AN-Evo1 is also available in different colors (black, brown and anthracite). It can be used monaural or binaural. For monaural, the hearing aid has one active temple and one none-active temple (dummy-temple). For binaural, the hearing aid has two active temples. The AN-Evo1 includes a digital programmable amplifier and a bone vibrator unit, which are connected directly in one housing. The bone vibrator of the device is held against the head and is driven electrically by the amplifier to transmit the amplified sound as vibrations to the underneath bones of the skull. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. For selecting the operating mode, a three position mode switch is used. The positions are O, OFF, T. Telecoil (induction coil) and M. Microphone. A Volume Control wheel is used to adjust the output power of the device. The AN-Evo1 is programmable via the HIPRO-Programming Box and BHMFit2 Fittingsoftware. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.
contact star evo1: Different to traditional air conduction hearing devices, by using bone conduction hearing aids contact star-evo1 the sound is produced in a broadband miniature vibration receiver and transmitted by direct skin contact to the mastoid, the area of the temple bone behind the ear. From here it is transmitted through the skull to the inner ear, where it is transformed into nerve impulses. The contact star evo1 is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different aid front-models. For mounting, extension tips and aid-fronts with different mechanical dimensions (lengths of extension tips, size of aid-fronts) are available. The contact star evo1 is also available in different colors (black, brown and anthracite). It can be used monaural or binaural. For monaural, the hearing aid has one active temple and one none-active temple (dummy-temple). For binaural, the hearing aid has two active temples. The contact star evo1 includes a high performance digital programmable amplifier and a bone vibrator unit, which are connected directly in one housing. The bone vibrator of the device is held against the head and is driven electrically by the amplifier to transmit the amplified sound as vibrations to the underneath bones of the skull. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. For selecting the operating mode, a three position mode switch is used. The positions are O..OFF, T.Telecoil (induction coil) and M..Microphone. A Volume Control wheel is used to adjust the output power of the device. The contact star evo1 is programmable via the HIPRO-Programming Box and BHMFit2 programming software. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.
contact mini: The contact mini is a digital bone conduction hearing aid. Sound is transmitted directly through the bones of the skull to the cochlea, bypassing the outer and middle ear. Contact mini consists of two interconnected units. An amplifier module and an bone vibrator. The amplifier module and the bone vibrator are connected through a wire cable. The amplifier module amplifies the sound and the bone vibrator converts them into vibrations. The bone vibrator has direct contact with the skin. The amplified sound moves through the bones of the inner ear, where it is directly converted into a neural stimulus. The contact mini is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different wearing such as headband, circlets and baseball caps. The contact mini is also available in different colors (black, blue and red). It can be used monaural or binaural. For monaural, the hearing aid use one active device and one bone vibrator. For binaural, the hearing aid uses two active devices and two bone vibrators. The contact mini includes a high performance digital programmable amplifier. The amplifier module is completely self-contained and has also a built in microphone for picking up sound. A Volume Control trimmer is used to adjust the output power of the device. The contact mini is programmable via the HIPRO-Programming Box and BHMFit2 programming software. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.
apollon: The apollon is also a bone conduction hearing aid. Unlike conventional hearing aids which depend upon acoustic coupling through air, the apollon is based on bone conduction technology. Sound is transmitted directly through the bones of the cochlea, bypassing the outer and middle ear. The apollon consists of a bone vibrator unit, a shirt pocket sized amplifier module and a wire cable for connecting the bone vibrator with the amplifier module. The bone vibrator is a convenient sized unit that is held against the head and is driven electrically to transmit the amplified sound as vibrations to the underneath bones of the skull. The amplifier module connects the bone vibrator through the wire cable and usually would be carried in the users pocket. The amplifier module is completely self-contained and is battery powered. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. As an added feature an auxiliary 3.5mm input jack allows the user to connect the apollon directly to TV, MP3 players, portable radios or even telephones without any additional adaptors. For selecting the operating mode, a four position mode switch is used. The positions are O..OFF, T..telecoil (induction coil), MT..microphone & telecoil (induction coil) and M..microphone. A Volume Control is used to adjust the output power of the device. Also, the possibility of a connection between via the DAI (Direct Audio Input) is available. A red LED (Light Emitting Diode) is used for optical low battery warning. The apollon is equipped with an high performance digital programmable amplifier system which can be adjusted via the BHMFit2 Programming software. The fitting will only be conducted by an audiologist, an hearing aid specialist or ENT.
The provided text describes a 510(k) premarket notification for several bone conduction hearing aids (AN-Evo1, contact star evo1, contact mini, apollon) seeking substantial equivalence to predicate devices (Viennatone AN - Fidelity F228 and Viennatone AS - Fidelity F229). The submission focuses on comparing the technical specifications and intended use of the new devices to the predicate devices.
However, the document does not contain any information about acceptance criteria, specific studies conducted to prove device performance against acceptance criteria, sample sizes used for test sets or training sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance studies.
The tables provided are "Comparison Tables" to demonstrate substantial equivalence to predicate devices, not performance against defined acceptance criteria from a study.
Therefore, most of the requested information cannot be extracted from the given text.
Here's an attempt to fill in what can be inferred from the provided context, noting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
As specific acceptance criteria (e.g., minimum audiological performance thresholds for the new devices) and dedicated study results proving performance against these criteria are not explicitly stated in this 510(k) summary, this table cannot be fulfilled in the requested format. Instead, the document provides comparison tables against predicate devices to demonstrate substantial equivalence, focusing on technical specifications. The implication is that if the new device's specifications are comparable or superior and do not raise new safety or effectiveness concerns, it meets an implied "acceptance criterion" of being substantially equivalent to a legally marketed device.
Here's a summary of the comparisons provided for the new devices against their predicates. It's crucial to understand these are comparisons for substantial equivalence, not results from a performance study against predefined acceptance criteria.
| Feature / Criterion (as presented for comparison) | AN-Evo1 (New Device) | Predicate (Viennatone AN - Fidelity F228) | contact star evo1 (New Device) | Predicate (Viennatone AS - Fidelity F229) | contact mini (New Device) | Predicate (Viennatone AS - Fidelity F229) | apollon (New Device) | Predicate (Viennatone AN - Fidelity F228) |
|---|---|---|---|---|---|---|---|---|
| Intended Use | Hearing Aid, Bone Conduction | Hearing Aid, Bone Conduction | Hearing Aid, Bone Conduction | Hearing Aid, Bone Conduction | Hearing Aid, Bone Conduction | Hearing Aid, Bone Conduction | Hearing Aid, Bone Conduction | Hearing Aid, Bone Conduction |
| Indications for Use | For mild to moderate hearing losses | For most severe hearing loss | For mild to moderate hearing losses | For moderate to severe hearing losses | For mild to moderate hearing losses | For moderate to severe hearing losses | For mild to moderate hearing losses | For most severe hearing loss |
| Circuit type | Digital | Analog | Digital | Analog | Digital | Analog | Digital | Analog |
| Programmable | Yes | No | Yes | No | Yes | No | Yes | No |
| Channels | Two | One | Two | One | Two | One | Four | One |
| Volume control | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Mode switch | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
| Direct Audio Input | No | No | No | No | No | No | Yes | No |
| Induction Coil | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes |
| Low Battery Indication | Yes | No | Yes | No | Yes | No | Yes | No |
| Trimmer | Yes | Yes | No | No | No | No | No | Yes |
| Program Switch Tones | Yes | No | Yes | No | Yes | No | Yes | No |
| Output-Limitation | Yes, MPO | Yes, Peak Clipping | Yes, MPO | No | Yes, MPO | No | Yes, MPO | Yes, Peak Clipping |
| Different Colors | Yes | No | Yes | Yes | Yes | Yes | No | No |
| Maximum Output (dBOFL) | 117 | 114 | 110 | 109 | 112 | 109 | 125 | 114 |
| Maximum Gain (dB) | 48 | 46 | 50 | 42 | 49 | 42 | 64 | 46 |
| HFA-OSPL90 (dBOFL) | 113 | 109 | 108 | 105 | 107 | 105 | 115 | 109 |
| Telephone coil sensitivity (dB) | 94 | 90 | 95 | 88 | N/A (no induction coil) | 88 | 94 | 90 |
| Equivalent input noise (dB) | 26 | 30 | 24 | 28 | 22 | 28 | 26 | 30 |
| Battery current (mA) | 1.2 | 2.2 | 1.2 | 2.15 | 1.25 | 2.15 | 15.6 | 2.2 |
| Battery life time (hours) | ~475 | ~260 | ~500 | ~280 | ~230 | ~280 | ~160 | ~260 |
| Power Source | Battery type 675 | Battery type 675 | Battery type 675 | Battery type 675 | Battery type 13 | Battery type 675 | 2 AA Batteries | Battery type 675 |
Study that proves the device meets acceptance criteria:
The provided document describes a 510(k) premarket notification, which is a submission to the FDA demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparisons of technological characteristics, intended use, and performance data (if available and relevant to substantial equivalence), rather than a de novo clinical trial proving performance against specific acceptance criteria.
The "study" in this context is the comparison of the new devices (AN-Evo1, contact star evo1, contact mini, apollon) to their respective predicate devices (K935701 Starkey Laboratories Inc. VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229). The conclusion reached by the FDA in their letter (page 12-13) is that the device is "substantially equivalent" to the predicate devices. The differences highlighted (e.g., digital circuitry, programmable features, battery life, different power sources) are deemed not to affect the safety and effectiveness of the device when used as labeled.
Missing Information:
The following requested details are not present in the provided document:
- 2. Sample sized used for the test set and the data provenance: No performance test set is explicitly mentioned or described as part of this 510(k) submission. The data provided are technical specifications.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth creation for a test set is described.
- 4. Adjudication method for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. These are hearing aids, not AI interpretation devices.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no ground truth for a performance study is described. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices.
- 8. The sample size for the training set: Not applicable, as no training set for an algorithm is described.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.