Meniere Disease and Hearing Aids

Hearing Loss, Sensorineural Clinical Trial

— MMA  

Official title:

Meniere Disease and Hearing Aids

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05582148
• Other study ID #: 38RC22.0289
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: October 2022
• Source: University Hospital, Grenoble
• Contact: Ashley BAGUANT, MD
• Phone: +33476765662
• Email: abaguant[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 20, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Meniere Disease

Intervention

Device:
• Hearing aids fitting
Fitting hearing aids and evaluating the results at 6 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

References & Publications (6)

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. — View Citation

Havia M, Kentala E, Pyykkö I. Hearing loss and tinnitus in Meniere's disease. Auris Nasus Larynx. 2002 Apr;29(2):115-9. — View Citation

Hood JD. Speech discrimination in bilateral and unilateral hearing loss due to Ménière's disease. Br J Audiol. 1984 Aug;18(3):173-7. — View Citation

McNeill C, McMahon CM, Newall P, Kalantzis M. Hearing aids for Ménière's syndrome: implications of hearing fluctuation. J Am Acad Audiol. 2008 May;19(5):430-4. — View 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 Ménière's disease. Acta Otolaryngol. 2014 Oct;134(10):1005-10. doi: 10.3109/00016489 — View Citation

Valente M, Mispagel K, Valente LM, Hullar T. Problems and solutions for fitting amplification to patients with Ménière's disease. J Am Acad Audiol. 2006 Jan;17(1):6-15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the comprehension in noise	Evaluation with the FrMatrix test of the noise comprehension at 6 months	6 months
Secondary	Correlation between the ear recruitment and the settings of the hearing aids	Correlation between the fowler test and the MPO modifications	6 months