TELE-DX
- Primary DI
- G860TELEDX0
- Brand
- TELE-DX
- Company
- Hear.com LLC
- Model
- 1.1
- Catalog number
- 0
- Device description
- hear.com (HDC) Tele-Dx is intended for professional use only. HDC Tele-Dx is intended to meet Type 3 audiometer requirements as per ANSI S3.6 1996 and EN-60645-1 2017.
- Published
- 2026-09-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| EWO | Audiometer |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EWO | Audiometer | Ear, Nose, Throat | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| G860TELEDX0 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Tone audiometer | An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation. |
Regulatory Flags#
- DUNS number
- 029640474
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 05711117244540 | Interacoustics | Interacoustics A/S | EWO | 2026-07-28 |
| 05711117244557 | Interacoustics | Interacoustics A/S | EWO | 2026-07-28 |
| 04260223147579 | Infant Insert Eartips 4.0mm (bag of 20) | PATH medical GmbH | EWO | 2026-07-24 |
| 04260223147586 | Infant Insert Eartips 3.5mm (bag of 20) | PATH medical GmbH | EWO | 2026-07-24 |
| 04260223147654 | Bone Conductor BC-2LD | PATH medical GmbH | EWO | 2026-07-24 |
| 04260223147661 | Bone Conductor BC-2LD | PATH medical GmbH | EWO | 2026-07-24 |
| 04260223147678 | Bone Conductor BC-2LD | PATH medical GmbH | EWO | 2026-07-24 |
| 04260223147975 | PIEP (2x2) | PATH medical GmbH | EWO | 2026-07-24 |
| 05713315000058 | 1052 OTOsuite | Natus Medical Denmark ApS | EWO | 2026-06-22 |
| 05713315000751 | 1066 OTOsuite | Natus Medical Denmark ApS | EWO | 2026-06-22 |
| 05713315000768 | 1052 OTOsuite | Natus Medical Denmark ApS | EWO | 2026-06-22 |
| 00817020020723 | Screener Cart | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020021027 | Toy Cabinet (Small) | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020021034 | Bone Vibrator w/Cable and Headband (B71) | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020021089 | DD45-300 Headphones with Pediatric Headband | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020021096 | DD45-300 Headphones with Easy Adjust Headband | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020021133 | OAE Probe OP23 | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020021140 | Diagnostic Cart | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020021218 | DD450 HF Headphones | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020021225 | DD45S (10 Ohms) Headphones | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020021232 | DD45S (10 Ohms) Headphones with Pediatric Headband | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020021249 | DD45S (10 Ohms) Headphones with Easy Adjust Headband | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-10 |
| 00817020020280 | Capella2 OAE Start-Up Kit | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-09 |
| 00817020021003 | B81 Bone Vibrator | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-09 |
| 00817020021010 | B81 Bone Vibrator Cable | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-09 |
| 00817020021164 | Bone Vibrator w/Cable and Headband (B81) for Aria | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-09 |
| 00817020021171 | Bone Vibrator Cable for Aria | INTELLIGENT HEARING SYSTEMS CORP. | EWO | 2026-06-09 |
| 00810046707562 | Grason-Stadler | Diagnostic Group LLC | EWO | 2026-06-04 |
| 05745000311064 | Oscilla | Oscilla A/S | EWO | 2026-05-29 |
| 05745000311095 | Oscilla | Oscilla A/S | EWO | 2026-05-29 |