Soundwave Hearing
Tulip ear domes are small silicone tips that attach to the receiver of a receiver-in-canal hearing aid and sit in the ear canal. The listed Soundwave Tulip is a one-size replacement dome…
Tulip ear domes are small silicone tips that attach to the receiver of a receiver-in-canal hearing aid and sit in the ear canal. The listed Soundwave Tulip is a one-size replacement dome for compatible Sontro hearing aids.
The 12 mm dome has a two-petal shape that fits over the receiver end. It forms the physical interface between the hearing-aid receiver and the ear canal.
Listed Item
TULIP-ONE SIZE (12MM)/991013-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids
Dome and Receiver
The Sontro manual describes Tulip domes as silicone pieces that attach to the receiver and gives a replacement procedure for removing the old dome and seating a new one over the receiver flange.
The filed pack contains ten replacement domes. This accessory fits the stated Sontro RIC application and is separate from the hearing aid, receiver and sound-processing electronics.
Who Else Makes It
Concentrated in Jiangsu (2), Fujian (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Luxshare Electronic Technology (Kunshan) Ltd. | Kunshan | Jiangsu | Contract manufacturer | 1 |
| Maintek Computer (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Huizhou Jinghao Medical Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Soundwave Hearing, LLC, United States |
|---|---|
| FDA product code | QUH |
| Device type | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3325 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2021-11-01 |
| Record revised | 2023-11-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 991014-SWH | In distribution | |
| 991016-SWH | In distribution | |
| 991012-SWH | In distribution | |
| 991004-SWH | In distribution | |
| 991013-SWH | In distribution | |
| 991010-SWH | In distribution | |
| 991005-SWH | In distribution | |
| 991015-SWH | In distribution | |
| 991009-SWH | In distribution | |
| 991006-SWH | In distribution | |
| 991007-SWH | In distribution | |
| 991019-SWH | In distribution | |
| 991011-SWH | In distribution | |
| 991008-SWH | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eargo SE | Eargo Inc | 16 |
| GN Hearing | GN Hearing A/S | 13 |
| Sontro Self-Fitting OTC Hearing Aids | Soundwave Hearing, LLC | 12 |
| Eargo 5 | Eargo Inc | 12 |
| Eargo 8 | Eargo Inc | 11 |
| Lexie Hearing | Hearx SA | 11 |
| Sony | WS Audiology USA, Inc. | 5 |
| Eargo 6 | Eargo Inc | 3 |
| Eargo 7 | Eargo Inc | 3 |
| Sonova Brand (multiple brand) | Sonova AG | 3 |
| Audialnet | Huizhou Jinghao Medical Technology Co., Ltd. | 2 |
| hear.com | WS Audiology USA, Inc. | 2 |
Showing 12 of 28. All products under Self-Fitting Air-Conduction Hearing Aid, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231550 | 2023-10-26 |
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.