510(k) Report

510(k) · Cleared

Cleared

Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid

K940667510(k) TraditionalCleared Aug 9, 1994174-day reviewClass I21 CFR 874.3300

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

Starkey Laboratories, Inc. · ESD Hearing Aid, Air-Conduction, Prescription

Cleared on Aug 9, 1994 after a 174-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Aug 9, 1994
Review
174 days
Class
Class I
Product code
ESD
Recalls
None
Predicates
0

11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1996: 3 descendants cleared1999: 3 descendants cleared2002: 2 descendants cleared2007: 1 descendant cleared2014: 1 descendant cleared2003: 1 descendant cleared1990200020102020
  1. This deviceK940667 Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidStarkey Laboratories, Inc. · 1994
  2. Descendant · cites it directly · 7 of its ownK963838 Starkey TM Air Conduction Tinnitus MaskerStarkey Laboratories, Inc. · 1996
  3. Descendant · cites it directly · 6 of its ownK964216 Starkey TM-3, TM-5 High Frequency Tinnitus MaskerStarkey Laboratories, Inc. · 1996
  4. Descendant · 2 generations on · 2 of its ownK982451 Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc. · 1999
  5. Descendant · 2 generations on · 1 of its ownK021202 UltraquietSound Technique System, LLC · 2002
  6. Descendant · 2 generations on · 1 of its ownK013253 Hisonic-TRD Tinnitus Relief DeviceHearing Innovations, Inc. · 2002

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1996: 31999: 32002: 22003: 12007: 12014: 1
1996high 3 (1996) · low 0 (1997)2026

Most influential descendants

Showing 5 of 11 · See all
  • K963838Starkey TM Air Conduction Tinnitus MaskerStarkey Laboratories, Inc. · 1996 · cites it directly7descendants
  • K964216Starkey TM-3, TM-5 High Frequency Tinnitus MaskerStarkey Laboratories, Inc. · 1996 · cites it directly6descendants
  • K982451Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc. · 1999 · 2 generations on2descendants
  • K021202UltraquietSound Technique System, LLC · 2002 · 2 generations on1descendant
  • K013253Hisonic-TRD Tinnitus Relief DeviceHearing Innovations, Inc. · 2002 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940667Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing AidStarkey Laboratories, Inc.1994—
+1K963838Starkey TM Air Conduction Tinnitus MaskerStarkey Laboratories, Inc.1996—
+1K964216Starkey TM-3, TM-5 High Frequency Tinnitus MaskerStarkey Laboratories, Inc.1996—
+2K982451Ttcghi-T and TTCTN3-T-TTinnitus Treatment Centers, Inc.1999—
+2K021202UltraquietSound Technique System, LLC2002—
+2K013253Hisonic-TRD Tinnitus Relief DeviceHearing Innovations, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
199930
200220
200310
200710
201410
FIG. 1 — Lineage of K940667, 1994–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Planning a device in ESD? 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 ESD device

  1. #1 K232999 Lyric4 Hearing Aidscore 8.4 · 5 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K963838Starkey TM Air Conduction Tinnitus MaskerStarkey Laboratories, Inc.19967
K964216Starkey TM-3, TM-5 High Frequency Tinnitus MaskerStarkey Laboratories, Inc.19966
K963995Starkey MA-3 Air Conduction Combination Hearing Aid/Tinnitus MaskerStarkey Laboratories, Inc.19960

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?

  • Of its descendants, K963838 (Starkey Laboratories, Inc., 1996) has gone furthest, with 7 descendants of its own.

How does its category compare?

All ESD devices

ESD Hearing Aid, Air-Conduction, Prescription: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ESD

1in 2024

2008: 12013: 12024: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ESD

Too few ESD 510(k)s in any year since 2007 to give a median.

Recalls per year · ESD

2in 2019

2010: 12018: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ESD

53in 2025

2007: 132008: 132009: 32010: 12011: 32012: 62013: 372014: 42015: 62016: 72017: 42018: 122019: 92020: 52021: 42022: 42023: 82024: 162025: 53
2007high 53 (2025) · low 1 (2010)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—013
20081—013
20090—03
20100—11
20110—03
20120—06
20131—037
20140—04
20150—06
20160—07
20170—04
20180—112
20190—29
20200—05
20210—04
20220—04
20230—08
20241—016
20250—053
20260—0—

More from Starkey Laboratories, Inc.

60 FDA decisions under this applicant name. See the company

  • K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc. · 2020
  • K030180Crescent Tinnitus Retaining Sound GeneratorStarkey Laboratories, Inc. · 2003
  • K970952Precise Impression KitStarkey Laboratories, Inc. · 1997
  • K964245Precise, Tynmpanette, and Xacto Impression KitsStarkey Laboratories, Inc. · 1997
  • K964340Portarem-3000, PFS-6000Starkey Laboratories, Inc. · 1997

Recent decisions in ESD

The ESD category page

  • K232999Lyric4 Hearing AidSonova AG · 2024
  • K130790LYRIC2Phonak, LLC · 2013
  • K081136Lyric Hearing AidInsound Medical, Inc. · 20081 recall
  • K021867Insound XT Series Hearing AidInsound Medical, Inc. · 2002
  • K003558Tci Combi (Tinnitus Control Instrument Combination)Siemens Hearing Instruments, Inc. · 2001

https://510kreport.com/device/K940667 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940667: Starkey CE-8 TML, Starkey CE-8 TMC Air Conduction Hearing Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940667

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026