Quality Control of CE-Certified Phonak Hearing Aids - 2018_07

Hearing Loss, Sensorineural Clinical Trial

Official title:

Quality Control of CE-Certified Phonak Hearing Aids - 2018_07

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555084
• Other study ID #: Sonova2018_07
• Status: Completed
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: June 22, 2018

Study information

• Verified date: September 2018
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 22, 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids

• Good written and spoken (Swiss) German language skills

• Healthy outer ear

• Ability to fill in a questionnaire (p/eCRF) conscientiously

• willingness to wear custom made Hearing aids

• Informed Consent as documented by signature

• Benefit with TFG tool at least on one ear

Exclusion Criteria:

• Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product

• Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)

• Limited ability to describe listening impressions/experiences and the use of the hearing aid

• Inability to produce a reliable hearing test result

• Limited dexterity (not able to change a 10size Hearing aid battery)

• no Benefit of the TFG tool on both ears

• Known psychological problems

• Central hearing disorders

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• Extension of Virto B-Titanium
In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
• Virto B-Titanium
In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TFG Fitrate	Another objective is to investigate whether at least 50% of the screened population will get a deeper fitted device by the use of the TFG tool, proven by modelling software	3 weeks
Primary	Visibility and Wearing Comfort	The primary objective of this study is to evaluate if Virto B-Titanium hearing aids measured with the Titanium FitGuide (TFG) (extension of Virto B-Titanium) are less visible (deeper) than modeling without TFG (Virto B-Titanium) while maintaining wearing comfort on adult participants (new and existing users) with mild to moderately-severe hearing loss (M and P receiver ).	3 weeks
Secondary	Measurement of acoustic Feedback Thresholds	Secondary objective is to compare the acoustic feedback thresholds of the TFG- and without TFG- modeled devices in regard of an adequate sealing effect of the respective devices. Thereby, feedback thresholds, measured with the Phonak Target fitting software, must be comparable to average feedback threshold values of the respective shell forms (IIC / CIC). Acceptable feedback thresholds must guarantee an insertion gain [in dB SPL] of at least 20 dB in a specific frequency range.	3 weeks