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FDA 510(k)

Self-Fitting hearing aids

K-Number: K221052 · 2023-09-25

ApplicantHuizhou Jinghao Medical Technology Co., Ltd.
Decision Date2023-09-25
Product CodeQUH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Self-Fitting hearing aids is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Jinghao Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-25 under 510(k) number K221052. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Self-Fitting hearing aids?

Self-Fitting hearing aids is a medical device that received FDA 510(k) clearance on 2023-09-25. The listed applicant is Huizhou Jinghao Medical Technology Co., Ltd.. The 510(k) number is K221052.

When did Self-Fitting hearing aids receive FDA 510(k) clearance?

Self-Fitting hearing aids received FDA 510(k) clearance on 2023-09-25, under 510(k) number K221052.

Who is the listed applicant for Self-Fitting hearing aids?

The FDA 510(k) record lists Huizhou Jinghao Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Self-Fitting hearing aids?

The FDA product code for Self-Fitting hearing aids is QUH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07690670WhatsApp AI Support vs Paper Support for First-Time Hearing Aid UsersRECRUITINGNCT06309264Comparing Hearing Aid Fitting Methods in Blast-exposed VeteransRECRUITINGNCT06560918Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing AidsCOMPLETEDNCT07255586Self-monitoring of Hearing Aids Using Artificial IntelligenceNOT_YET_RECRUITINGNCT07703800The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant UsersRECRUITING

Related Devices (Code: QUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)GN Hearing A/SK233747Concha Sol Hearing Aids (CL-1001)Concha LabsK233464WSA Self-Fitting Hearing Aid Gen 2Wsaud A/SK231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLCK223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned , Ltd.K230538All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidSonova AG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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