510(k) · Cleared

Cleared

Cochlear Baha Implant System

K121317510(k) TraditionalCleared Oct 12, 2012163-day reviewClass II21 CFR 874.3302

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cochlear Americas · MAH Hearing Aid, Bone Conduction, Implanted

Cleared on Oct 12, 2012 as substantially equivalent to K100360 (Cochlear Americas, 2010) after a 163-day review. Its family tree reaches back 1 generation to 2010. 1 later device descends from it.

Decided: Oct 12, 2012
Review: 163 days
Class: Class II
Product code: MAH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K100360 (2010). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK100360 BIA300 Series Implant and Abutment, BI300 Implant, BA300 AbutmentCochlear Americas · 2010
This deviceK121317 Cochlear Baha Implant SystemCochlear Americas · 2012
Descendant · cites it directly · 0 of its ownK182116 BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas · 2018

Most influential descendants

Showing 1 of 1 · See all

K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K100360	BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment	Cochlear Americas	2010	—
0 (this device)	K121317	Cochlear Baha Implant System	Cochlear Americas	2012	—
+1	K182116	BA310 Abutment, BIA310 Implant/Abutment	Cochlear Americas	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K121317, 2010–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MAH device

#1 K261142 Ponto 5 Mini; Ponto 5 Superpowerscore 15.2 · 12 generations · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K100360	BIA300 Series Implant and Abutment, BI300 Implant, BA300 Abutment Summary page 1 …300, Class 11 Classification Panel: Ear Nose and Throat Product Code: LXB 510(k): K100360 16 of 317 Cochlear- IIearnwAk" F. Purpose of Submission…	Cochlear Americas	2010	—

Also cleared against K100360: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K182116	BA310 Abutment, BIA310 Implant/Abutment	Cochlear Americas	2018	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K182116 (Cochlear Americas, 2018) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K100360.

How does its category compare?

All MAH devices

MAH Hearing Aid, Bone Conduction, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MAH

1in 2021

2007high 3 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAH

124in 2015

2007high 124 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAH

No recall names MAH since 2007.

Adverse event reports per year · MAH

562in 2025

2007high 742 (2023) · low 0 (2009)2025

MAUDE reports naming product code MAH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	9
2008	1	—	2
2009	0	—	0
2010	0	—	0
2011	1	—	0
2012	2	—	4
2013	0	—	21
2014	0	—	46
2015	3	124	52
2016	1	—	309
2017	0	—	614
2018	1	—	629
2019	0	—	635
2020	0	—	692
2021	1	—	709
2022	0	—	711
2023	0	—	742
2024	0	—	621
2025	0	—	562
2026	1	—	—

What is it indicated for?

The Cochlear Baha@ auditory osseointegrated implant system using model BA400 abutment is intended for the following patients and indications for use: • Patients aged 5 and older • Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB3 HL for use with the BP100 sound processor, 55…

Read the full statement (252 words)

The Cochlear Baha@ auditory osseointegrated implant system using model BA400 abutment is intended for the following patients and indications for use:

• Patients aged 5 and older

• Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB3 HL for use with the BP100 sound processor, 55 dB HL for use with the Intenso sound processor, 55dcb HL for use with the BPI1O Power sound processor, and 65 db HL for use with the Cordelle 11Sound Processor.

• Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conductive thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1,2, and 3 kHz), or less than a 15dB difference at individual frequencies..

• Patients who suffer from unilateral sensorineural deafness in one ear with norm al hearing in the other ear (i.e. Single-sided deafness: SSDTM). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.

• Baha for SSID is also indicated for any patient whd is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC GROS.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K121317 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121317: Cochlear Baha Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121317

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026