Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Baha 5 Power Sound Processor

K-Number: K161123 · 2016-05-20

Decision Date2016-05-20
Product CodeLXB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Baha 5 Power Sound Processor is the device name listed in this FDA 510(k) record. The listed applicant is Cochlear Americas. It received FDA 510(k) clearance on 2016-05-20 under 510(k) number K161123. The device is classified under product code LXB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Baha 5 Power Sound Processor?

Baha 5 Power Sound Processor is a medical device that received FDA 510(k) clearance on 2016-05-20. The listed applicant is Cochlear Americas. The 510(k) number is K161123.

When did Baha 5 Power Sound Processor receive FDA 510(k) clearance?

Baha 5 Power Sound Processor received FDA 510(k) clearance on 2016-05-20, under 510(k) number K161123.

Who is the listed applicant for Baha 5 Power Sound Processor?

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

What is the FDA product code for Baha 5 Power Sound Processor?

The FDA product code for Baha 5 Power Sound Processor is LXB.

Other records listing Cochlear Americas 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.

View all 17 devices →

Related Devices (Code: LXB)

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.

Official Source

View on FDA Database →

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