510(k) · Cleared
ClearedBA310 Abutment, BIA310 Implant/Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cochlear Americas · MAH Hearing Aid, Bone Conduction, Implanted
Cleared on Dec 19, 2018 as substantially equivalent to K100360 (Cochlear Americas, 2010) and 2 other predicates after a 135-day review. Its family tree reaches back 9 generations to 1986.
- Decided
- Dec 19, 2018
- Review
- 135 days
- Class
- Class II
- Product code
- MAH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K861971 (1986). 24 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 5 generations between
- 3 generations backK103594 Ponto Pro PowerOticon Medical AB · 2011
- 2 generations backK132775 Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013
- 1 generation backK161671 Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB · 2016
- This deviceK182116 BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas · 2018
Show all 9 generations
- Root · 9 generations backK861971 Xomed Audiant Bone Conductor W/Improved AA CoilXomed, Inc. · 1986
- 8 generations backK955713 Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
- 7 generations backK984162 Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
- 6 generations backK992872 Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc. · 1999
- 5 generations backK080363 Baha Cordelle IICochlear Bone Anchored Systems AB · 2008
- 4 generations backK090720 Cochlear Baha BP100Cochlear Bone Anchored Systems AB · 2009
- 3 generations backK103594 Ponto Pro PowerOticon Medical AB · 2011
- 2 generations backK132775 Ponto Plus and Ponto Plus PowerOticon Medical AB · 2013
- 1 generation backK161671 Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB · 2016
- This deviceK182116 BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K861971 | Xomed Audiant Bone Conductor W/Improved AA Coil | Xomed, Inc. | 1986 | — |
| −8 | K955713 | Nobelpharma Bone Anchored Hearing Aid | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K984162 | Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric Use | Nobelpharma USA, Inc. | 1999 | — |
| −6 | K992872 | Branemark Bone-Anchored Hearing Aid (Baha) Cordelle II | Entific Medical Systems, Inc. | 1999 | — |
| −5 | K080363 | Baha Cordelle II | Cochlear Bone Anchored Systems AB | 2008 | — |
| −4 | K090720 | Cochlear Baha BP100 | Cochlear Bone Anchored Systems AB | 2009 | — |
| −3 | K103594 | Ponto Pro Power | Oticon Medical AB | 2011 | — |
| −2 | K132775 | Ponto Plus and Ponto Plus Power | Oticon Medical AB | 2013 | — |
| −1 | K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | 2016 | — |
| 0 (this device) | K182116 | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K100360 | BIA300 Series Implant and Abutment, BI300 Implant, BA300 AbutmentSummary page 4…and Throat Product Codes: MAH C. Predicate Devices: Device 510(k) no. Manufacturer BA300 Cochlear Baha Abutment K100360 Cochlear Bone Anchored Solutions (primary predicate device) AB BA400 Cochlear Baha Abutment K12… | 2010 |
| * | K121317 | Cochlear Baha Implant SystemSummary page 4…BA300 Cochlear Baha Abutment K100360 Cochlear Bone Anchored Solutions (primary predicate device) AB BA400 Cochlear Baha Abutment K121317 Cochlear Bone Anchored Solutions (additional predicate device) AB Ponto System K16… | 2012 |
| * | K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerSummary page 4…BA400 Cochlear Baha Abutment K121317 Cochlear Bone Anchored Solutions (additional predicate device) AB Ponto System K161671 Oticon Medical AB (additional predicate device) Device Description Intended Use The Cochlear Baha Connec… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 2.5 years on median.
- None of the 24 ancestors has a recall.
- 2 other devices also cite its predicate K100360.
How does its category compare?
All MAH devicesMAH Hearing Aid, Bone Conduction, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · MAH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MAH
124in 2015
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 9 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 0 | — | 0 | 46 |
| 2015 | 3 | 124 | 0 | 52 |
| 2016 | 1 | — | 0 | 309 |
| 2017 | 0 | — | 0 | 614 |
| 2018 | 1 | — | 0 | 629 |
| 2019 | 0 | — | 0 | 635 |
| 2020 | 0 | — | 0 | 692 |
| 2021 | 1 | — | 0 | 709 |
| 2022 | 0 | — | 0 | 711 |
| 2023 | 0 | — | 0 | 742 |
| 2024 | 0 | — | 0 | 621 |
| 2025 | 0 | — | 0 | 562 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Cochlear Baha Connect System (Baha sound processors and implant/abutment system) 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 dB HL for use with the Baha 4 and Baha 5 sound…
Read the full statement (291 words)
The Cochlear Baha Connect System (Baha sound processors and implant/abutment system) 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 dB HL for use with the Baha 4 and Baha 5 sound processors, 55 db HL for use with the Baha 5 Power sound processors, and 65 db HL for use with the Baha 5 SuperPower Sound Processors.
* 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 normal hearing in the other ear (i.e. Single-sided deafness: SSD™). 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 SSD is also indicated for any patient who 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 CROS.
Specific models of the Cochlear Baha abutments can be used with either the Cochlear Baha Connect System or compatible sound processors from Oticon Medical AB. Refer to the Cochlear Baha abutment labeling for a list of compatible Oticon Medical sound processors.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182116: BA310 Abutment, BIA310 Implant/Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182116
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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