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FDA 510(k)

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid

K-Number: K230538 · 2023-06-16

ApplicantSonova AG
Decision Date2023-06-16
Product CodeQUH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid is the device name listed in this FDA 510(k) record. The listed applicant is Sonova AG. It received FDA 510(k) clearance on 2023-06-16 under 510(k) number K230538. 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 All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid?

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid is a medical device that received FDA 510(k) clearance on 2023-06-16. The listed applicant is Sonova AG. The 510(k) number is K230538.

When did All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid receive FDA 510(k) clearance?

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid received FDA 510(k) clearance on 2023-06-16, under 510(k) number K230538.

Who is the listed applicant for All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid?

The FDA 510(k) record lists Sonova AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid?

The FDA product code for All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid 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.

NCT06138665Evaluation of a New Noise Reduction Strategy in Hearing AidsCOMPLETEDNCT07501312Remote Microphone Performance Comparison in Adults With Hearing LossCOMPLETEDNCT07711249Clinical Benefit of Hearing Aid Tinnitus Feature on Tinnitus-Related Annoyance in Tinnitus Patients in BelgiumNOT_YET_RECRUITINGNCT07224919AutoFocus360 Sound Quality Preference and Claims StudyCOMPLETEDNCT07414329Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device KitCOMPLETEDNCT07526428Investigating the DNN Noise Reduction Feature in Phonak Hearing Aids Using Ecological Momentary AssessmentTERMINATED

Other records listing Sonova AG as applicant

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.

K232999Lyric4 Hearing Aid

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, LLCK221052Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd.K223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned , Ltd.

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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