Neuromonics (and other discontinued cleared devices) for Tinnitus: What Does the Evidence Show?
Sound Therapy
Current evidence
A once heavily marketed $5,000 'acoustic desensitization' program — FDA-cleared, weakly evidenced, now largely defunct.
Evidence strength: Limited (2/5) · Tier 5 — weak or unsupported · Evidence independence: Primarily sponsor-supported.
Spectrally modified music + counseling over ~6 months (Neuromonics Tinnitus Treatment), prominent in the 2000s at ~$4,000–6,000. The company is essentially inactive; Tinnitus UK could not locate a current UK provider (2024). Similar fate: SoundCure Serenade (S-tones, FDA 510(k) K111293, 2011) — defunct since ~2017 with no independent RCT ever published.
Did tinnitus loudness improve?
None shown. No controlled loudness evidence.
Did tinnitus distress improve?
Limited. Original Australian trials (~N=35) were small, company-sponsored, without adequate sham; US insurers classify it investigational.
Loudness means the tinnitus percept itself became quieter (psychoacoustic matching or loudness ratings). Distress means questionnaire scores such as THI/TFI, sleep, anxiety or quality of life improved — the sound may be unchanged. A THI/TFI improvement is never evidence the tinnitus got quieter.
How strong is the evidence?
Weak sponsor-only evidence and a defunct delivery network: Tier 5.
Has the result been independently replicated?
Same group/sponsor only. All supporting evidence company-run (Davis et al.); no independent replication.
What are the limitations?
- Sponsor-only evidence
- Insurers: investigational
- Company effectively gone
Conflicts of interest: All supporting evidence was company-run.
What should patients know about safety?
Safety evidence: Strong. Benign.
Is it available?
Regulatory status: FDA 510(k) cleared (historical); company largely inactive. 510(k) clearance = substantial equivalence to existing maskers, not proven efficacy. Several tinnitus maskers hold such clearances.
Availability: Scarce; residual providers only · Europe: Effectively unavailable · Cost (approx.): Historically $4,000–6,000
What the studies found
Neuromonics third clinical trial (two active variants, no control)
Davis PB, et al. · Ear & Hearing · 2007 · N=35 · Randomized comparison of TWO VARIANTS of the same Neuromonics treatment — no untreated or sham arm
91% had ≥40% TRQ improvement (mean 65%) — but with no independent control arm, this cannot be attributed to the treatment rather than placebo/natural course.
Frequently quoted by marketing as '91% success'; the design cannot support that framing. Registration and funding details unable to verify from the record read.
Related treatments
- Sound therapy & masking — Widely used, low-risk, valued by many — but never proven better than placebo in controlled trials.
- Notched sound / notched music therapy — Music with your tinnitus frequency carved out — a modest, unconfirmed loudness effect in tonal tinnitus.
- Levo System (sleep-time sound matching) — FDA-cleared sound therapy played during sleep, matched to your tinnitus 'sound print' — one small positive…
Evidence last reviewed: 2026-09-03 · Evidence included through: 2026-09-03 · Confidence: moderate. Open the interactive evidence profile.
This page summarizes published research for education. It is not medical advice; it cannot say what will work for any individual. Discuss treatment decisions with a qualified clinician.