Hearing aids and tinnitus

Personalized hearing aids to ameliorate tinnitus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28370

Enrollment

Registered

2021-04-08

Start date

2021-10-28

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Interventions

During 13 weeks, participant will use hearing aids with 3 different amplification techniques: standard amplification, notched amplification and boosted amplification. After a week of adaptation, parti

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - No reported neurological or psychiatric disorders (excluding tinnitus and hearing loss); - High frequency hearing loss; - Moderate- to moderate-severe- degree of hearing loss (PTA of 1, 2 and 4 kHz = 35 dB); - Chronic tinnitus (lasting more than 6 months); - Tinnitus percept described as tonal (or at least being able to perceive a pitch during a tinnitus matching); - Tinnitus pitch = 6 kHz, and in the hearing loss region; - Using hearing aids for at least the last 6 months; - Written informed consent;

Exclusion criteria

Exclusion criteria: Non-conformance to any of the inclusion criteria stated above;

Design outcomes

Primary

Measure	Time frame
There was a small reduction of the TFI score after the adaptation process, possibly due to a placebo effect.  The TFI score  did not differ significantly from the standard setting after using the notched or the boosted settings. Regardless of the TFI outcomes, most participants had an individual preference for a particular setting. Notch-filtered and boosted amplification did not provide better tinnitus suppression than standard amplification, although notched amplification performed better than boosted amplification. The individual preferences highlighted the importance of tailor-made approaches to hearing aid amplification in clinical practice. Further studies should explore the differences among patient’s tinnitus and their preference for a hearing aid setting.	—

Measure

Time frame

There was a small reduction of the TFI score after the adaptation process, possibly due to a placebo effect.  The TFI score  did not differ significantly from the standard setting after using the notched or the boosted settings. Regardless of the TFI outcomes, most participants had an individual preference for a particular setting. Notch-filtered and boosted amplification did not provide better tinnitus suppression than standard amplification, although notched amplification performed better than boosted amplification. The individual preferences highlighted the importance of tailor-made approaches to hearing aid amplification in clinical practice. Further studies should explore the differences among patient’s tinnitus and their preference for a hearing aid setting. 

—

Secondary

Measure	Time frame
Additionally, the following psychoacoustic measures will take place: - Changes in tinnitus pitch - Changes in tinnitus loudness - Auditory Handicap - Hours of hearing aid use	—

Contacts

Public ContactJose López Santacruz

University Medical Center Groningen

j.lopez.santacruz@umcg.nl+31633316550

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)