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Status unknownNCT00730834CALMUpdated Aug 25, 2009

Customized Acoustic Stimulation for Long Term Medical Benefit for the Relief of Tinnitus and Hyperacusis

A Phase 4 interventional study of Oasis in Tinnitus and Hyperacusis, sponsored by Neuromonics, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-25.

Sponsored by Neuromonics, Inc. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2009), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
53
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Neuromonics TInnitus Treatment CALM study is a multi site study of 100 adult subjects with clinically significant disturbing tinnitus to evaluate outcome measures using the FDA cleared Neuromonics treatment after 6, 12, 24 and 36 months. Patients must be meet certain inclusion criteria and they are also required to pay for the all costs of the treatment. Subjects will be provided a modest participation fee at 6, 12, 24 and 36 months upon completion of patient questionnaires (subjects must have access to a computer and internet in order to complete on line questionnaires).

02

Conditions studied

  • Tinnitus
  • Hyperacusis

Keywords

  • tinnitus
  • ringing in the ears
  • buzzing
  • static
  • hyperacusis
  • loudness discomfort
  • Clinically
  • significant
  • discomfort
03

In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's enrollment of 53 is below the median of 60 across 368 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

This is the only study on the registry with Neuromonics, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years of age,
  • TRQ of at least 17 or above,
  • Able to pay for the treatment,
  • Not using any other treatment for tinnitus,
  • Access to computer and internet,
  • Compliant patient

Exclusion criteria

Exclusion Criteria:

  • Hearing PTA > 50 dB, score on HADS of greater than 11 on the anxiety and depression scale,
  • Not willing to follow the protocol
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Interventions

  • DeviceOasis

    Digital sound player that provides customized acoustic stimulus based on subjects hearing thresholds

    Also known as: Neuromonics Oasis Tinnitus Treatment

06

What researchers measure

Primary outcomes

  1. Pre and post treatment scores on Tinnitus reaction questionnaire

    Time frame: 6, 12, 24, 36 months

Secondary outcomes

  1. Tinnitus Handicap Inventory, Hospital Anxiety and Depression Scale,

    Time frame: 6, 12, 24, 36 months

07

Study locations

1 site
  • Silverstein Ear Institute
    Sarasota, Florida 34239, United States
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00730834
Lead sponsor
Neuromonics, Inc.
First posted
Aug 8, 2008
Start date
Jun 2007
Primary completion
Dec 2010 (estimated)
Completion
Dec 2010 (estimated)
Last update
Aug 25, 2009

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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