Bio-Logic
The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for…
The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test.
2manufacturers in China registered for this device type
33catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
All of them in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fastsound Acoustic Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Zoomax Technology Co., Limited | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Natus Medical Incorporated, United States |
|---|---|
| FDA product code | EWO |
| Device type | Audiometer |
| Device class | Class 2 |
| Regulation | 21 CFR 874.1050 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2017-03-31 |
| Record revised | 2026-01-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Handling environment humidity 15 to 95 % RH; Storage environment temperature -20 to 70 °C; Handling environment temperature 15 to 40 °C |
| Packaging | 101603 of 300, 101600 of 60, 101603 of 100, 101600 of 20 |
| Sizes | Length 0.5 to 42 in; length 11.6 to 15.1 mm; outer diameter 0.11 to 0.705 in; length 8 to 12 ft; outer diameter 6 to 13.1 mm; width 0.88 to 4 in; weight 400 g; depth 1.7 in |
| Distribution end date | 2026-01-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Disposable Subdermal Needle | 24 | In distribution | |
| Tiptrode Electrodes Adults | 20 | Withdrawn | |
| Insert Earphone Plastic Tip ER2 | 10 | Withdrawn | |
| OAE Tree Tip | Length 15.1 mm | 100 | Withdrawn |
| Sinser Tip White | 10 | Withdrawn | |
| OAE Tree Tip Preemie | Length 15.1 mm | 20 | Withdrawn |
| OAE Foam Tip Adult | Outer Diameter 0.54 in | 20 | Withdrawn |
| ABR Standard Insert Earphones 8 ft | Length 8 ft | Withdrawn | |
| Disposable Snap Electrodes | Length 1.31 in | Withdrawn | |
| ABaer | Weight 400 g | Withdrawn | |
| Halo Ear Muffin with Tab Electrode | Withdrawn | ||
| Insert Earphone Tip ER2 Adult | Outer Diameter 13.1 mm | 50 | Withdrawn |
| Insert Earphone Tip ER2 Pediatric | Outer Diameter 9.1 mm | 50 | Withdrawn |
| Insert Earphone Tip Adult | 50 | Withdrawn | |
| OAE Tree Tip Preemie | Length 15.1 mm | 100 | Withdrawn |
| Insert Earphone Tip Adapter Infant | Withdrawn | ||
| OAE Tree Tip | Length 15.1 mm | 20 | Withdrawn |
| OAE Jumbo Tip | Outer Diameter 0.110 in | 20 | Withdrawn |
| Tiptrode Electrodes Pediatric | 20 | Withdrawn | |
| OAE Ear Probe | Withdrawn | ||
| OAE 6mm Tip | Outer Diameter 6 mm | 20 | Withdrawn |
| OAE Foam Tip Pediatric | Outer Diameter 0.38 in | 20 | Withdrawn |
| OAE Foam Tip Pediatric | Outer Diameter 0.38 in | 100 | Withdrawn |
| Halo Ear Muffin Adapter Tube | Withdrawn | ||
| OAE Foam Tip Adult | Outer Diameter 0.54 in | 100 | Withdrawn |
| OAE 6mm Tip | Outer Diameter 6 mm | 100 | Withdrawn |
| ABR Standard Insert Earphone 12 ft | Length 12 ft | Withdrawn | |
| Ear Clip Electode Pediatric | Length 42 in | Withdrawn | |
| Standard Insert Earphone 8 ft | Length 8 ft | Withdrawn | |
| OAE Jumbo Tip | Outer Diameter 0.705 in | 100 | Withdrawn |
| Foam Tips Pediatric | 50 | Withdrawn | |
| Insert Earphone Tip Jumbo | 24 | Withdrawn | |
| Standard Insert Earphones 12 ft | Length 12 ft | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RadioEar A/S | Interacoustics A/S | 131 |
| GN Otometrics A/S | Natus Medical Denmark ApS | 88 |
| Audiometer | Etymotic Research, Inc. | 73 |
| Siemens | WS Audiology USA, Inc. | 57 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 29 |
| Real-EAR | WS Audiology USA, Inc. | 26 |
| Sanibel Supply A/S | Interacoustics A/S | 18 |
| Natus | Natus Medical Incorporated | 14 |
| Grason-Stadler | Diagnostic Group LLC | 12 |
| Interacoustics | Interacoustics A/S | 12 |
| Oscilla | Inmedico A/S | 12 |
| Single Use Eartip | Etymotic Research, Inc. | 12 |
Showing 12 of 348. All products under Audiometer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112247 | 2012-04-02 |
| K111618 | 2011-12-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.