Figure 1
Oricle names in FDA records
| Oricle 2.0 | GUDID entry for factory model JH-A490, tied to the name by five voluntary MAUDE reports | QUF on GUDID; QUH on the reports | Over-the-counter air-conduction hearing aid | Exempt on GUDID | Reports only |
|---|---|---|---|---|---|
| Oricle Pro | None found under this name | Not established | Not established | Not established | None found |
| Oricle TrueFit | None found under this name | Not established | Not established | Not established | None found |
| Oricle Hearing LLC (the company) | Establishment registration 3027202846 | QUH | Self-fitting air-conduction hearing aid, over the counter | K221052 (applicant: Huizhou Jinghao) | Empty on the listing |
| Brand Oricle: JH-A26A, JH-A170, JH-A17BT, JH-D26AT | Four GUDID entries | QUF | Over-the-counter air-conduction hearing aid | Exempt on GUDID | Factory numbers only |
How to read these numbers (1)
- Each row is what FDA's public files held on the search date. A row marked not established means our searches found no record under that name, and FDA may hold a filing under another name.
- Oricle,oriclehearing.com/…/oricle-hearing-aid-pro
- Oricle,oriclehearing.com/…/oricle-truefit-behind…
- FDA (openFDA),api.fda.gov/device/registrationlisting.json
- FDA (openFDA),api.fda.gov/device/udi.json
- FDA (openFDA),api.fda.gov/device/event.json
Oracle or Oricle: which brand is this?
The company spells its name Oricle, with an i. If you searched for Oracle hearing aids, this is the brand you are likely after.
Oricle Hearing LLC runs oriclehearing.com and holds an FDA establishment registration in San Diego, CA, with Lifetime Well LLC as owner-operator. The site describes over-the-counter aids for mild to moderate hearing loss, sold direct, in three models: Oricle 2.0, Oricle Pro and Oricle TrueFit.
What do Oricle hearing aids cost?
In October 2026, Oricle listed the 2.0 at $149.99, the Pro at $199.99 and the TrueFit at $339.99 on the product pages linked in the sources below. Each box holds two aids and a charging case.
The specification tables on those pages set the models apart:
- 2.0: in-the-ear, analog chip, 2 listening programs, no noise reduction, no feedback cancellation.
- Pro: in-the-canal, digital chip, 4 listening programs, with noise reduction and feedback cancellation.
- TrueFit: receiver-in-canal, digital chip, 2 listening programs, 16 channels, with noise reduction and feedback cancellation.
Oricle takes returns within 30 days of delivery. The aids must go back within 7 days of creating the return label, and the label cost comes out of your refund, so a return can cost you that fee. The site also calls its aids HSA and FSA eligible; FSA eligibility covers how those accounts treat hearing aids.
This is a dated reading of Oricle's own pages, and a price at another seller can differ. Confirm the figure before you order.
What FDA records show for each Oricle model
Oricle's site says all three models are listed in FDA's over-the-counter hearing aid database. The table above shows what we could tie to each name in FDA's public files on October 30, 2026.
Oricle 2.0: one indirect link. GUDID, FDA's device identifier database, holds five entries under the brand name Oricle. They carry factory model numbers, and JH-A490 is one of them. Five voluntary MAUDE reports name the Oricle 2.0 together with JH-A490, the only tie we found between that product name and a factory model. The JH-A490 entry has code QUF, a Class 1 over-the-counter air-conduction aid under 874.3300, marked exempt from premarket review. The reports use a different code, QUH, so the records do not line up.
Oricle Pro and TrueFit: no named record. No GUDID entry or MAUDE report in these searches carries either name, and a listing search on the proprietary name Oricle returned no match. Ask Oricle which FDA record applies to the model you are buying.
K221052: on the company's listing, without a model. The listing for registration 3027202846 shows code QUH, a self-fitting over-the-counter aid, under 510(k) K221052, and its product name field is empty. The applicant on that 510(k) is Huizhou Jinghao Medical Technology, and FDA found it substantially equivalent on September 25, 2023. Its summary names model JH-D58 and describes control through the "JH Smart" app, whereas Oricle's tables say no app is required on any of the three. Five establishments list the same number, including Audicon, Oxiline and Spoonwood Ecommerce, so the number alone does not identify an Oricle model.
Registered does not mean approved. Under 21 CFR 807.39, holding an establishment registration number does not denote FDA approval of the establishment or its products.
Who makes Oricle hearing aids?
GUDID names one company on all five Oricle entries: Huizhou Jinghao Medical Technology Co., Ltd, the 510(k) applicant from Huizhou, China. FDA's listing also types Oricle Hearing LLC's San Diego address as a manufacturing establishment. Neither record says where a given pair was built.
Huizhou Jinghao appears on many other labels: 92 GUDID entries across 53 brand names. Model JH-A490 sits under six brand names, among them Acevion, CUEME, FLAYGO and Prime Sound Hearing. Model JH-D26AT sits under eight, among them Sharper Image and equate. A shared model number points to a common maker's designation. It does not show that the tuning, parts or support match from one label to the next.
Oricle complaints and recalls in FDA records
We searched FDA's recall and adverse event data through openFDA on October 30, 2026.
Recalls: no match. The recall and enforcement databases returned nothing for Oricle as a product or firm name. The recall database also returned nothing for Lifetime Well, Huizhou Jinghao or K221052.
Adverse event reports: five, unverified. MAUDE, whose data was last updated on October 13, 2026, returned five distinct reports under the Oricle and Lifetime Well names, all marked voluntary. MW5171941, received June 25, 2025, is coded Use of Device Problem and Device Markings/Labelling Problem. MW5190637 to MW5190640, all received July 13, 2026, share one UPC and cite one another, so they may describe a single case. They say a hearing aid went too far into the ear canal and had to be removed with instruments, and they blame a reseller's ear tip sizes.
Five reports give neither a rate nor a verdict on quality. openFDA warns that this data lacks information about how often a device is used, and reports can come from voluntary reporters such as patients and consumers. A firm-name search on Huizhou Jinghao returned 2 more reports filed under other product names, which we leave out of the Oricle count.
Where to buy Oricle hearing aids
Oricle's site describes its aids as sold direct, and the 2026 FDA reports refer to a reseller. Our price and return readings come from Oricle's own pages, so stock and terms at Amazon, Walmart, Target or Costco need checking on each retailer's site. On any other listing, look at the seller's name and its return window before you pay.
Frequently asked questions
Are Oracle hearing aids really any good?
Specifications and FDA files answer part of this. Oricle lists the 2.0 as analog with no noise reduction or feedback cancellation, and the Pro and TrueFit as digital with both. Recall searches on October 30, 2026 found no match, and MAUDE holds five unverified reports. How an aid works for you is what the return window is for.
Is Oracle a hearing aid or an amplifier?
A hearing aid, in FDA's classification: the Oricle entries and the company's listing carry hearing aid codes, QUF and QUH. The amplifier wording comes from how the devices work. Oricle says the 2.0 uses pre-tuned analog amplification, and the K221052 summary says those self-fitting aids amplify sound for adults 18 or older with perceived mild to moderate hearing impairment.
Sources
FDA details come from exact-name openFDA searches and the K221052 summary, archived with their date. Report counts are de-duplicated by report number. Oricle's prices and specifications are read from its own product pages with the month of reading, and prices stay out of the table.
- https://www.oriclehearing.com/products/oricle-hearing-aid
- https://www.oriclehearing.com/products/oricle-hearing-aid-pro
- https://www.oriclehearing.com/products/oricle-truefit-behind-the-ear-hearing-aid
- https://www.oriclehearing.com/
- https://www.oriclehearing.com/policies/terms-of-service
- https://api.fda.gov/device/registrationlisting.json?search=registration.name%3A%22Oricle%22&limit=100
- https://api.fda.gov/device/registrationlisting.json?search=proprietary_name%3A%22Oricle%22&limit=100
- https://api.fda.gov/device/510k.json?search=k_number%3AK221052&limit=10
- https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221052.pdf
- https://api.fda.gov/device/registrationlisting.json?search=k_number%3AK221052&limit=100
- https://api.fda.gov/device/udi.json?search=brand_name%3A%22Oricle%22&limit=100
- https://api.fda.gov/device/udi.json?search=company_name%3A%22Huizhou+Jinghao%22&limit=100
- https://api.fda.gov/device/event.json?search=device.brand_name%3A%22Oricle%22&limit=100
- https://api.fda.gov/device/recall.json?search=product_description%3A%22Oricle%22&limit=50
- https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Oricle%22&limit=50
- https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Lifetime+Well%22&limit=50
- https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Huizhou+Jinghao%22&limit=50
- https://api.fda.gov/device/recall.json?search=k_numbers%3AK221052&limit=50
- https://api.fda.gov/device/enforcement.json?search=product_description%3A%22Oricle%22&limit=50
- https://api.fda.gov/device/enforcement.json?search=recalling_firm%3A%22Oricle%22&limit=50
- https://api.fda.gov/device/event.json?search=device.manufacturer_d_name%3A%22Huizhou+Jinghao%22&limit=100
- https://open.fda.gov/apis/device/event/
- https://www.govinfo.gov/content/pkg/CFR-2024-title21-vol8/pdf/CFR-2024-title21-vol8-sec807-39.pdf
- https://www.medicare.gov/coverage/hearing-aids
Cost and coverage research, not medical advice. FDA files describe registrations, clearances and reports, not how an aid will work for you; talk to a hearing care professional about your hearing.