Lab Evaluation of Novel Hearing Aid Coupling Method

Hearing Loss Clinical Trial

Official title:

Lab Evaluation of Novel Hearing Aid Coupling Method

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05377359
• Other study ID #: SRF-1082
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: June 2023
• Source: Sonova AG
• Contact: Bilal Sheikh, MClSc
• Phone: 2268083260
• Email: bilal.sheikh[@]sonova.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of different hearing aid coupling methods including two states of a novel coupling method and two traditional coupling methods.

Description:

An important decision in the fitting of hearing aids is the selection of the coupling method. Examples of coupling options include universal rubber domes and custom earmolds. When selecting a coupling method, the degree of venting must be considered.

Venting refers to an opening in the coupling method to allow for the sound transmission from the tympanic membrane to the external environment. The degree of venting has a significant impact on the hearing aid user's experience. More closed (or more occluded) coupling means the vent is smaller or non-existent. Occluded fittings allow for more low-frequency amplification, which improves hearing aid performance like directionality, noise reduction and streaming sound quality. However, occluded fittings lead to complaints of the occlusion effect, in which users complain of their own voice as sounding "boomy" and can also lead to a build-up of pressure in the ear canal which users may find uncomfortable. To relieve the occlusion effect and pressure build-ups, more vented (sometimes called open) couplings can be used by allowing low-frequency sounds to leave the ear. Despite a degradation in hearing aid outcomes like directionality, noise reduction and streaming sound quality, open fits are typically preferred for speech quality and own-voice perception - at least for hearing aid users with milder losses and near-normal thresholds at low frequencies.

The fact that two coupling options are associated with two different outcomes means that hearing aid practitioners need to make an important trade-off. Either their patient will enjoy the full breadth of the hearing aid's signal processing potential (via a more occluded fit) or their patient will enjoy better own-voice perception and relief of air pressure in the ear canal(via a more open fit). A coupling method that allows for the best of both options is left to be desired.

A recent development in coupling methods has allowed us to take advantage of both open and closed fittings in a single solution. More occluded coupling allows for more low-frequency amplification which improves hearing aid performance in areas such as directionality, noise reduction, and streaming sound quality. Whereas, open coupling options reduces complaints of the occlusion effect and is preferred for speech quality and own-voice perception by hearing aid users with milder losses. This novel coupling method will function as both an open and closed fitting depending on the environment the listener is in. State 1 is dedicated to loud environments where the listener can take advantage of noise management solutions and for streaming so they can enjoy better sound quality. State 2 is dedicated to quieter environments where the listener can enjoy better physical comfort and own-voice naturality.

This novel coupling method should theoretically exploit the benefits of both open and closed coupling methods. This study is designed to see how this novel coupling method compares to traditional domes and how this coupling method performs in various listening situations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Hearing aid candidate

• Meets the fitting requirements for novel and traditional coupling options

• Healthy outer ear - no visible congenital or traumatic deformity

• Symmetrical hearing loss

• No air-bone gap greater than 10 dB at 500, 1000, 2000, and 4000 Hz

• Ability to answer questions and repeat sentences

• No history of problematic tinnitus or pain/discomfort from loud sounds

• No history of active drainage from the ears in the past 90 days

• Informed consent as documented by signature.

Exclusion Criteria:

• Limited mobility (not able to attend scheduled visits)

• Inability to produce reliable hearing test results

• History of active drainage from the ear in the previous 90 days

• Abnormal appearance of the eardrum and ear canal

• Known psychological problems.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Device:
• Recordings of Hearing Aids with Open Domes
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled to open domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
• Recordings of Hearing Aids with Closed Domes
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with closed domes. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
• Recordings of Hearing Aids with Novel State 1
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its first state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.
• Recordings of Hearing Aids with Novel State 2
Receiver-in-the-Canal hearing aids will be used which are programmed to the participant's hearing loss and will be coupled with the new coupling method in its second state. Recordings will be made of hearing aid output on a head and torso simulator and played back to participants over headphones.

Locations

Country	Name	City	State
Canada	Western University - National Centre for Audiology	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Sonova AG	Sonova Canada Inc., Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (7)

Cox RM, Alexander GC, Gilmore C. Development of the Connected Speech Test (CST). Ear Hear. 1987 Oct;8(5 Suppl):119S-126S. doi: 10.1097/00003446-198710001-00010. — View Citation

Gabrielsson A, Schenkman BN, Hagerman B. The effects of different frequency responses on sound quality judgments and speech intelligibility. J Speech Hear Res. 1988 Jun;31(2):166-77. doi: 10.1044/jshr.3102.166. — View Citation

Kuk F, Keenan D, Lau CC. Vent configurations on subjective and objective occlusion effect. J Am Acad Audiol. 2005 Oct;16(9):747-62. doi: 10.3766/jaaa.16.9.11. — View Citation

Saleh HK, Folkeard P, Macpherson E, Scollie S. Adaptation of the Connected Speech Test: Rerecording and Passage Equivalency. Am J Audiol. 2020 Jun 8;29(2):259-264. doi: 10.1044/2019_AJA-19-00052. Epub 2020 Mar 20. — View Citation

Vasil-Dilaj KA, Cienkowski KM. The influence of receiver size on magnitude of acoustic and perceived measures of occlusion. Am J Audiol. 2011 Jun;20(1):61-8. doi: 10.1044/1059-0889(2010/09-0031). Epub 2011 Jan 28. — View Citation

Voss SC, Pichora-Fuller MK, Ishida I, Pereira A, Seiter J, El Guindi N, Kuehnel V, Qian J. Evaluating the benefit of hearing aids with motion-based beamformer adaptation in a real-world setup. Int J Audiol. 2022 Aug;61(8):642-654. doi: 10.1080/14992027.2021.1948120. Epub 2021 Aug 7. — View Citation

Winkler A, Latzel M, Holube I. Open Versus Closed Hearing-Aid Fittings: A Literature Review of Both Fitting Approaches. Trends Hear. 2016 Feb 15;20:2331216516631741. doi: 10.1177/2331216516631741. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sound Quality Ratings while steaming	Hearing aid recordings of different coupling options will be presented via a Multiple Stimuli with Reference and Anchor (MUSHRA) paradigm, where participants will rate and compare sound quality attributes between them.	60 minutes
Secondary	Situational preference ratings	Hearing aid recordings of different listening situations through different coupling options will be presented via a MUSHRA paradigm, where participants will indicate preferences between different recordings.	45 Minutes