Skip to content

Effects of Low-Gain Hearing Aids (LGHA) versus Remote Microphone Hearing Systems (RMHS) for School-aged Participants with Listening Difficulties (LiD) and suspected auditory processing disorders (APD)

Effects of Low-Gain Hearing Aids (LGHA) versus Remote Microphone Hearing Systems (RMHS) for School-aged Participants with Listening Difficulties (LiD) and suspected auditory processing disorders (APD) - LearningEar3

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00041086
Enrollment
219
Registered
2026-07-24
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-03

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 intervention group will consist of 174 children with listening difficulties (LiD) and suspected Auditory Processing Disorder (APD). Participants will be randomly assigned to one of two tr

Sponsors

Klinik für Phoniatrie und Pädaudiologie, Universitätsklinikum Münster
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) a peripheral hearing loss has been excluded by speech audiometry and pure tone audiometry assessing air conduction and bone conduction thresholds at 0.5, 1, 2, 4, 6, 8 and 10 kHz (for 8 kHz air conduction only), as well as otoacoustic emissions (TEOAE), Tympanometry and 2 kHz ipsilateral acoustic reflex. (2) a cognitive deficit has been excluded by a nonverbal intelligence test using the Wechsler Nonverbal Scale of Ability (WNV) or or the Wechsler Intelligence Scale for Children – Fifth Edition (WISC-V) or the Snijders-Oomen non-verbal intelligence test – revision for children aged 2 to 8 years (SON-R 2-8 or 6-40). Several different test procedures are accepted, as many children have already undergone developmental diagnostics as part of previous clinical differential diagnostics, thus avoiding unnecessary additional stress for the participants. (3) Developmental Language Disorders and/or reading and spelling disorders were examined using the test procedures described below for differential diagnosis and diagnosis of comorbidities either as part of the study protocol at T0 or as part of the clinical preliminary/differential diagnosis at our clinic or a social pediatric center/corresponding institution. In the latter case, test results can be used provided that the testing was carried out within the last year. (4) Listening Difficulties (LiD) are identified using the Evaluation of Children's Listening and Processing Skills (ECLiPS) questionnaire and a suspected/present APD is diagnosed with at least one abnormal test result (< 5th percentile or < -1.65 SD) from the following test battery: a. speech audiometry in quiet and in noise (Oldenburger Satztest, OlSa [Oldenburg Sentence Test, OlSa] or Oldenburger Kindersatztest, OlKiSa [Oldenburg Children Sentence Test, OlKiSa] in noise and Göttinger Kindersprachverständnistest [Göttingen Children's Language Comprehension Test] or Freiburger Test für Einsilber [Freiburg test for one silver] in quiet) b. The LiSN-U test assessing speech understanding in spatially separated and co-located speech-simulating noise c. the dichotic listening test by Uttenweiler or Feldmann, depending on age d. the Mottier Test, assessing auditory memory, auditory sequencing, and identification and differentiation of phonemes using chains of nonsense syllables e. the subtests Sentence Repetition, Rhyming, Substitution of Vowels, Replacing Consonants and Elision of Consonants from the Potsdam-Illinois Test für Psycholinguistische Fähigkeiten (P-ITPA; Ballaschk et al. 2010) f. the subtests just noticeable differences of non-speech stimuli (Tone Duration, Frequency, Sinusoidal Amplitude Modulation) from the Bochum Auditory and Speech Discrimination (BASD) Screening (Neumann 2013, Neumann et al., submitted), and (5) parents or guardians and – if appropriate – the child have given their written consent for participation in the study.

Exclusion criteria

Exclusion criteria: Unstable medical conditions or conditions that would place the individual at risk for injury, lack ofooperation, or lack of consent of the subject or the parents, teachers or the legal guardian.

Design outcomes

Primary

MeasureTime frame
Educational listening abilities, as measured by the Listening Inventory for Education - Revised (L.I.F.E.-R), Teacher Version, measured after 3 months of usage of the RMHS or HA, or conservative therapy.

Secondary

MeasureTime frame
(1) Everyday listening abilities, as measured by the VClass Questionnaire (2) Parent evaluations on the Evaluation of Children's Listening and Processing Skill (ECLIPS) (3) The acceptance of hearing aids compared to RMHS, measured by 1. The wish to continue usage, 2. The reported/ read out wearing time (4) Speech comprehension in noise, measured with the Oldenburg Children's Sentence Test (OLKiSa / OlSa), measured using the RMHS / LGHA, compared to unaided (Delta as outcome parameter) (5) Listening fatigue, measured by the vanderbilt fatigue scale

Countries

Germany

Contacts

Public ContactAmelie Hesping

Klinik für Phoniatrie und Pädaudiologie, Universitätsklinikum Münster

lernohr@ukmuenster.de+492518359831

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026