Clinical trial NCT05582148: Meniere Disease and Hearing Aids
Official title: Meniere Disease and Hearing Aids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniere Disease
Hearing Loss, Sensorineural
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cohort followed up
Primary purpose: TREATMENT

Brief summary: Patients with unilateral Meniere Disease often a distortion that causes difficulties to provide hearing aids to these patients. Those patients have two main problems: disorders in noise comprehension due to interaural threshold difference and increase in the distortion during dizziness crisis.

Due to these problems, some people cannot be fitting with hearing aids because the compression needed is too high or the discomfort in noise is not bearable for patients.

Our aim is to evaluate and to propose a way to adjust hearing aids to restore binaural hearing with comfort.


Eligibility criteria: Inclusion Criteria:

* Age over 18 y.o
* Meniere disease as define by the Barany Society
* Unilateral deafness with a threshold over 50dB
* Normal ear with a threshold above 30dB
* Interaural threshold difference of at least 30dB
* Patient who has already an hearing aids and satisfied with it

Exclusion Criteria:

* Absence of consent of the patient or not able to give it
* Patient with hearing aids well fitted

Primary outcomes:
measure: Evaluation of the comprehension in noise
timeFrame: 6 months
Secondary outcomes:
measure: Correlation between the ear recruitment and the settings of the hearing aids
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: Ashley BAGUANT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cubick J, Buchholz JM, Best V, Lavandier M, Dau T. Listening through hearing aids affects spatial perception and speech intelligibility in normal-hearing listeners. J Acoust Soc Am. 2018 Nov;144(5):2896. doi: 10.1121/1.5078582.
citation: Havia M, Kentala E, Pyykko I. Hearing loss and tinnitus in Meniere's disease. Auris Nasus Larynx. 2002 Apr;29(2):115-9. doi: 10.1016/s0385-8146(01)00142-0.
citation: Hood JD. Speech discrimination in bilateral and unilateral hearing loss due to Meniere's disease. Br J Audiol. 1984 Aug;18(3):173-7. doi: 10.3109/03005368409078945.
citation: McNeill C, McMahon CM, Newall P, Kalantzis M. Hearing aids for Meniere's syndrome: implications of hearing fluctuation. J Am Acad Audiol. 2008 May;19(5):430-4. doi: 10.3766/jaaa.19.5.5.
citation: Sato G, Sekine K, Matsuda K, Ueeda H, Horii A, Nishiike S, Kitahara T, Uno A, Imai T, Inohara H, Takeda N. Long-term prognosis of hearing loss in patients with unilateral Meniere's disease. Acta Otolaryngol. 2014 Oct;134(10):1005-10. doi: 10.3109/00016489.2014.923114. Epub 2014 Jul 16.
citation: Valente M, Mispagel K, Valente LM, Hullar T. Problems and solutions for fitting amplification to patients with Meniere's disease. J Am Acad Audiol. 2006 Jan;17(1):6-15. doi: 10.3766/jaaa.17.1.2.