Long term effects of personnel FM-systems in children with auditory processing disorder and difficulties in understanding speech in noise

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005192

Enrollment

Registered

2013-08-19

Start date

2013-12-02

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

F80.20

Interventions

Group 1: The study is indented to examine whether FM systems do not only improve speech understanding noise in children with auditory processing disorders, but also improve long-term sound perception

Eligibility

Sex/Gender

All

Age

6 Years to 14 Years

Inclusion criteria

Inclusion criteria: Regular hearing threshold in quiet (air conduction =15dB, bone conduction = 10 dB on both sides) Regular tympanogram on both sides. Detectable TEOAE, stimulus stability = 90% (80%), reproducibility = 75% (60%), SNR = 3dB in at least 3 frequencies Regular speech understanding in quiet (Freiburger Monosyllabic Speech Test: at least 95% correct at 65 dB, Göttinger Pediatric Speech Test: at leat 90 % correct at 65 dB Visual perception: standard values = 85 (e.g., Motor Free Visual Perception Quotient, MVPR Vers. 3), non-verbal IQ = 85 (e.g., CMM 1-3 oder or HAWIK Vers. IV) APD diagnosed according to consensus paper DGPP (Gross et al. 2010), considering current norm values (e.g., Kiese-Himmel and Risse 2009)

Exclusion criteria

Exclusion criteria: Hyperacusis, which could prevent subjects from wearing FM receivers in the study. Confirmation through regular loudness scaling results (Würzburger loudness scaling in frequencies from 500 Hz - 4000 Hz) Attention and concentration deficit (DCL-HKS questionnaire) Usage of psychotropic drugs (e.g., Methylphenidat)

Design outcomes

Primary

Measure	Time frame
The outcome measures for the study are related to auditory processing performance and cognitive auditory perception performance, which are critical for academic performance in school. A child which learns to write has to be able to distinguish between phonemes, recognize them in spoken language, and memorize what has been said. A therapy for APD has to improve performance in these key issues. The primary outcome is speech sound discrimitation (Heidelberger Lautanalyse- und Differenzierungstest H-LAD, Brunner et al. 1998): improved T-scores and/or percentages. The primary outcome parameter is measured at the time of diagnosis, 6-7 months after diagnosis (control group only), at fitting the FM systems, 6-7 months after fitting, and 12 months after fitting.	—

Measure

Time frame

The outcome measures for the study are related to auditory processing performance and cognitive auditory perception performance, which are critical for academic performance in school. A child which learns to write has to be able to distinguish between phonemes, recognize them in spoken language, and memorize what has been said. A therapy for APD has to improve performance in these key issues. The primary outcome is speech sound discrimitation (Heidelberger Lautanalyse- und Differenzierungstest H-LAD, Brunner et al. 1998): improved T-scores and/or percentages. The primary outcome parameter is measured at the time of diagnosis, 6-7 months after diagnosis (control group only), at fitting the FM systems, 6-7 months after fitting, and 12 months after fitting.

—

Secondary

Measure	Time frame
1. Auditory memory (Mottier test and K-ABC--subtest): improved raw scores, T-scores and/or percentages 2. Phonological awareness (subtests from the Psycholinguistic Development Test (PET)): improved raw scores, T-scores and/or percentages 3. Perception errors (Diagnostic Spelling Test (DRT, WRT)): improved T-scores and/or percentages The outcome parameters are measured at the time of diagnosis, 6-7 months after diagnosis (control group only), at fitting the FM systems, 6-7 months after fitting, and 12 months after fitting.	—

Measure

Time frame

1. Auditory memory (Mottier test and K-ABC--subtest): improved raw scores, T-scores and/or percentages 2. Phonological awareness (subtests from the Psycholinguistic Development Test (PET)): improved raw scores, T-scores and/or percentages 3. Perception errors (Diagnostic Spelling Test (DRT, WRT)): improved T-scores and/or percentages The outcome parameters are measured at the time of diagnosis, 6-7 months after diagnosis (control group only), at fitting the FM systems, 6-7 months after fitting, and 12 months after fitting.

—

Countries

Germany

Contacts

Public ContactRainer Schönweiler

Abt. für Phoniatrie und Pädaudiololgie Universitätsklinikum Schleswig-Holstein (UK SH), Campus Lübeck

rainer.schoenweiler@phoniatrie.uni-luebeck.de0451 500 3485

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026